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Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study) (TRAFIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928927
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : April 12, 2017
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Intervention Drug: Telmisartan
Enrollment 58
Recruitment Details 58 participants enrolled to Step 1 between January 6, 2014 and April 13, 2015. Step 1 was a run-in period to ensure successful pre-randomization biopsies were obtained. 44 participants did have successful Step 1 biopsy and were randomized to Step 2 between January 13, 2014 and April 22, 2015.
Pre-assignment Details All participants enrolled to Step 1. Participants with successful Step 1 biopsies and eligible for Step 2 were randomized to the two study arms using a 2:1 allocation ratio with permuted blocks of size 3 and without institutional balancing. There was no stratification.
Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Period Title: Overall Study
Started 29 15
Completed 27 14
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             1             1
Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug Total
Hide Arm/Group Description

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Total of all reporting groups
Overall Number of Baseline Participants 29 15 44
Hide Baseline Analysis Population Description
All Step 2 randomized participants with data available for specific measures.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 29 participants 15 participants 44 participants
47
(41 to 51)
50
(39 to 52)
48
(41 to 52)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
18-29 years
0
   0.0%
2
  13.3%
2
   4.5%
30-39 years
6
  20.7%
2
  13.3%
8
  18.2%
40-49 years
12
  41.4%
3
  20.0%
15
  34.1%
50-59 years
11
  37.9%
6
  40.0%
17
  38.6%
60-69 years
0
   0.0%
2
  13.3%
2
   4.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
Female
2
   6.9%
1
   6.7%
3
   6.8%
Male
27
  93.1%
14
  93.3%
41
  93.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
Hispanic or Latino
7
  24.1%
1
   6.7%
8
  18.2%
Not Hispanic or Latino
22
  75.9%
14
  93.3%
36
  81.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  20.7%
8
  53.3%
14
  31.8%
White
22
  75.9%
7
  46.7%
29
  65.9%
More than one race
1
   3.4%
0
   0.0%
1
   2.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
White Non-Hispanic
16
  55.2%
6
  40.0%
22
  50.0%
Black Non-Hispanic
5
  17.2%
8
  53.3%
13
  29.5%
Hispanic (Regardless of Race)
7
  24.1%
1
   6.7%
8
  18.2%
More than one race
1
   3.4%
0
   0.0%
1
   2.3%
IV drug history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
No History
25
  86.2%
13
  86.7%
38
  86.4%
Previous History
4
  13.8%
2
  13.3%
6
  13.6%
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 29 participants 15 participants 44 participants
25.4
(23.3 to 29.8)
23.7
(21.4 to 26.6)
25.0
(22.6 to 28.4)
Waist circumference   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 28 participants 14 participants 42 participants
92
(85 to 100)
86
(81 to 96)
88
(84 to 99)
[1]
Measure Analysis Population Description: Participants with non-missing waist circumference data.
Waist-to-hip ratio   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 28 participants 14 participants 42 participants
0.94
(0.91 to 0.98)
0.91
(0.86 to 0.95)
0.93
(0.89 to 0.97)
[1]
Measure Analysis Population Description: Participants with non-missing waist circumference data.
CD4+   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 28 participants 15 participants 43 participants
604
(438 to 812)
556
(444 to 906)
588
(444 to 841)
[1]
Measure Analysis Population Description: Participants with non-missing CD4+ data.
HIV-1 RNA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
<40 copies/ml
24
  82.8%
11
  73.3%
35
  79.5%
40 - <200 copies/ml
3
  10.3%
3
  20.0%
6
  13.6%
>= 200 copies/ml
2
   6.9%
1
   6.7%
3
   6.8%
Lymphoid Tissue Collagen I Deposition   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Percent area stain positive
Number Analyzed 24 participants 15 participants 39 participants
15.3
(6.5 to 22.1)
12.6
(10.3 to 19.1)
13.9
(8.4 to 20.8)
[1]
Measure Analysis Population Description: Participants with non-missing lymphoid tissue collagen I deposition data.
Adipose Tissue Collagen I Deposition  
Median (Inter-Quartile Range)
Unit of measure:  Percent area stain positive
Number Analyzed 29 participants 15 participants 44 participants
1.51
(0.54 to 2.69)
2.83
(1.36 to 4.53)
2.11
(0.63 to 3.45)
1.Primary Outcome
Title Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48
Hide Description Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing lymphoid tissue collagen I deposition.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 17 12
Median (Inter-Quartile Range)
Unit of Measure: percent area stain positive
-2.44
(-10.60 to 3.77)
-6.08
(-11.66 to 5.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Telmisartan, Arm B: No Study Drug
Comments Null hypothesis: theta = 0.50
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments No adjustment for multiple comparisons
Method Theta statistic; DeLong & Clarke-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Theta statistic
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.26 to 0.73
Estimation Comments The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.
2.Primary Outcome
Title Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Hide Description Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing subcutaneous abdominal adipose tissue collagen I deposition.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 16 9
Median (Inter-Quartile Range)
Unit of Measure: percent area stain positive
-1.43
(-10.61 to 4.17)
0.36
(-6.57 to 6.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Telmisartan, Arm B: No Study Drug
Comments Null hypothesis: theta = 0.50
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments No adjustment for multiple comparisons
Method Theta statistic; DeLong & Clarke-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Theta statistic
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.31 to 0.83
Estimation Comments The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.
3.Secondary Outcome
Title Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing lymphoid tissue fibronectin deposition.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 19 11
Median (Inter-Quartile Range)
Unit of Measure: percent area stain positive
0.01
(-0.40 to 0.35)
0.61
(-0.09 to 1.40)
4.Secondary Outcome
Title Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing adipose tissue fibronectin deposition.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and followed the week 0-48 evaluation schedule.
Overall Number of Participants Analyzed 22 12
Median (Inter-Quartile Range)
Unit of Measure: percent area stain positive
-0.82
(-4.00 to 0.45)
-4.01
(-6.02 to -1.63)
5.Secondary Outcome
Title Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing adipose collagen VI deposition.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 12
Median (Inter-Quartile Range)
Unit of Measure: percent area stain positive
-0.41
(-4.03 to 0.31)
-1.36
(-2.04 to -0.67)
6.Secondary Outcome
Title Highest Grade Non-biopsy-related Adverse Event
Hide Description

Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant.

Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.

NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol.

Time Frame after baseline to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All Step 2 participants
Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 29 15
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0
12
  41.4%
6
  40.0%
Grade 1
0
   0.0%
0
   0.0%
Grade 2
11
  37.9%
3
  20.0%
Grade 3
5
  17.2%
5
  33.3%
Grade 4
1
   3.4%
1
   6.7%
7.Secondary Outcome
Title Change in IL-6 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing IL-6.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.50
(-0.80 to 0.11)
-0.01
(-0.29 to 0.27)
8.Secondary Outcome
Title Change in IL-6 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing IL-6.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.53
(-0.69 to 0.04)
0.04
(-0.48 to 0.85)
9.Secondary Outcome
Title Change in IL-6 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing IL-6.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.46
(-0.86 to 0.13)
-0.03
(-0.48 to 1.18)
10.Secondary Outcome
Title Change in IL-7 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing IL-7.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
0.48
(-0.21 to 2.18)
-0.32
(-4.34 to 0.37)
11.Secondary Outcome
Title Change in IL-7 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing IL-7.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
0.51
(-0.13 to 2.32)
-1.36
(-3.94 to 0.44)
12.Secondary Outcome
Title Change in IL-7 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing IL-7.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
0.06
(-0.82 to 1.73)
0.53
(-1.18 to 2.28)
13.Secondary Outcome
Title Change in Adiponectin From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing adiponectin.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
177.20
(-1624.50 to 1949.70)
161.00
(-528.30 to 1597.35)
14.Secondary Outcome
Title Change in Adiponectin From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing adiponectin.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-582
(-1709.30 to 714.20)
1222.60
(-867.60 to 3278.15)
15.Secondary Outcome
Title Change in Adiponectin From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing adiponectin.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-138.70
(-1935.20 to 1521.70)
113.80
(-3150.00 to 907.80)
16.Secondary Outcome
Title Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CICP.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-2.14
(-14.94 to 8.45)
-9.10
(-27.38 to 14.29)
17.Secondary Outcome
Title Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CICP.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-13.78
(-37.69 to 5.93)
-1.17
(-24.43 to 40.16)
18.Secondary Outcome
Title Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CICP.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-10.76
(-40.50 to 27.78)
-6.10
(-31.99 to 6.36)
19.Secondary Outcome
Title Change in Hyaluronic Acid From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing hyaluronic acid.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-0.03
(-8.46 to 16.63)
3.14
(-7.29 to 14.42)
20.Secondary Outcome
Title Change in Hyaluronic Acid From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing hyaluronic acid.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-1.62
(-18.32 to 1.19)
3.71
(-5.83 to 30.20)
21.Secondary Outcome
Title Change in Hyaluronic Acid From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing hyaluronic acid.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
-2.74
(-18.52 to 9.84)
-1.79
(-6.96 to 14.49)
22.Secondary Outcome
Title Change in sCD14 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing sCD14.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: mcg/ml
-0.03
(-0.37 to 0.08)
0.05
(-0.06 to 0.25)
23.Secondary Outcome
Title Change in sCD14 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing sCD14.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: mcg/ml
0.06
(-0.19 to 0.26)
-0.08
(-0.15 to 0.09)
24.Secondary Outcome
Title Change in sCD14 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing sCD14.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: mcg/ml
-0.08
(-0.26 to 0.12)
0
(-0.17 to 0.36)
25.Secondary Outcome
Title Change in sCD163 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing sCD163.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
34.08
(-33.96 to 174.04)
0.88
(-45.16 to 106.08)
26.Secondary Outcome
Title Change in sCD163 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing sCD163.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
58.72
(-44.52 to 206.52)
9.58
(-49.40 to 56.72)
27.Secondary Outcome
Title Change in sCD163 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing sCD163.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
31.14
(-200.04 to 160.20)
5.32
(-117.80 to 96.84)
28.Secondary Outcome
Title Change in TGF-β1 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β1.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
793.37
(-2080.11 to 3877.98)
-1074.87
(-5328.36 to 603.32)
29.Secondary Outcome
Title Change in TGF-β1 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β1.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
175.02
(-1249.67 to 4478.09)
678.43
(-3983.91 to 2816.12)
30.Secondary Outcome
Title Change in TGF-β1 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β1.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-319.17
(-3429.94 to 1203.98)
-516.45
(-2307.66 to 2090.85)
31.Secondary Outcome
Title Change in TGF-β2 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β2.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
70.74
(-135.73 to 147.97)
-129.40
(-272.80 to -5.13)
32.Secondary Outcome
Title Change in TGF-β2 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β2.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
75.84
(-39.61 to 134.71)
-134.68
(-345.89 to -8.64)
33.Secondary Outcome
Title Change in TGF-β2 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β2.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
44.45
(-201.77 to 164.44)
-55.94
(-201.52 to 119.60)
34.Secondary Outcome
Title Change in TGF-β3 From Baseline to Week 4
Hide Description Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β3.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
31.26
(-39.82 to 254.89)
-95.17
(-450.42 to -10.83)
35.Secondary Outcome
Title Change in TGF-β3 From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β3.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
34.64
(-16.14 to 226.95)
-68.01
(-341.55 to 101.57)
36.Secondary Outcome
Title Change in TGF-β3 From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing TGF-β3.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.47
(-176.53 to 175.68)
-55.21
(-163.05 to 135.04)
37.Secondary Outcome
Title Change in Circulating CD4+ T Cell Count From Baseline to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at baseline.
Time Frame baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD4+ count.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 10
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
-17.50
(-133 to 26)
59.50
(-24 to 108)
38.Secondary Outcome
Title Change in Circulating CD4+ T Cell Count From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD4+ count.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 12
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
13
(-55 to 95)
61.5
(-16.5 to 186.5)
39.Secondary Outcome
Title Change in Circulating CD4+ T Cell Count From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD4+ count.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
9
(-24 to 45)
97
(4 to 111)
40.Secondary Outcome
Title Change in Circulating CD8+ T Cell Count From Baseline to Week 12
Hide Description Absolute change was calculated as the value at week 12 minus the value at baseline.
Time Frame baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD8+ count.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 10
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
-33.5
(-130 to 111.5)
83
(30 to 154)
41.Secondary Outcome
Title Change in Circulating CD8+ T Cell Count From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD8+ count.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 12
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
-3.5
(-97 to 103.5)
80.5
(-8 to 181.5)
42.Secondary Outcome
Title Change in Circulating CD8+ T Cell Count From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD8+ count.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
10
(-72 to 101)
97
(-24 to 169)
43.Secondary Outcome
Title Change in Fasting Glucose From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing fasting glucose.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
4
(-3 to 8)
2
(-5 to 12)
44.Secondary Outcome
Title Change in Fasting HDL Cholesterol From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing fasting HDL cholesterol.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-1
(-6 to 1)
-4
(-7 to 6)
45.Secondary Outcome
Title Change in Fasting Insulin From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing fasting insulin.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 22 13
Median (Inter-Quartile Range)
Unit of Measure: uIU/ml
3
(-1 to 4)
0
(-2 to 8)
46.Secondary Outcome
Title Change in Fasting LDL Cholesterol From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing fasting LDL cholesterol.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-12
(-30.2 to 12)
-7.4
(-20.6 to 18.8)
47.Secondary Outcome
Title Change in Fasting Total Cholesterol From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing fasting total cholesterol.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-8
(-23 to 4)
-2
(-8 to 9)
48.Secondary Outcome
Title Change in Fasting Triglycerides From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing fasting triglycerides.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
7
(-23 to 29)
-16
(-23 to 63)
49.Secondary Outcome
Title Change in HOMA-IR From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing HOMA-IR.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Median (Inter-Quartile Range)
Unit of Measure: (mg/dl)x(uIU/ml)/405
0.76
(-0.02 to 1.01)
-0.04
(-0.42 to 1.03)
50.Secondary Outcome
Title Prevalence of Metabolic Syndrome at Week 24.
Hide Description

Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40" (101.6 cm) in men, >35" (88.9 cm) in women with the exception of Asian-Americans: >35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.

NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing metabolic syndrome components.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 11
Measure Type: Count of Participants
Unit of Measure: Participants
Metabolic syndrome
6
  28.6%
1
   9.1%
No metabolic syndrome
15
  71.4%
10
  90.9%
51.Secondary Outcome
Title Presence of Metabolic Syndrome at Week 48.
Hide Description Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40" (101.6 cm) in men, >35" (88.9 cm) in women with the exception of Asian-Americans: >35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing metabolic syndrome components.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 13
Measure Type: Count of Participants
Unit of Measure: Participants
Metabolic syndrome
7
  33.3%
0
   0.0%
No metabolic syndrome
14
  66.7%
13
 100.0%
52.Secondary Outcome
Title Change in Waist Circumference From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing waist circumference.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 10
Median (Inter-Quartile Range)
Unit of Measure: cm
0.90
(-0.15 to 3.40)
0.57
(-3.87 to 5.80)
53.Secondary Outcome
Title Change in Waist Circumference From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing waist circumference.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 12
Median (Inter-Quartile Range)
Unit of Measure: cm
0.77
(-2.03 to 2.93)
-0.08
(-4.95 to 5.05)
54.Secondary Outcome
Title Change in Waist-to-hip Ratio From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing waist-to-hip ratio.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 10
Median (Inter-Quartile Range)
Unit of Measure: waist cm : hip cm
0
(-0.01 to 0.03)
0.01
(0 to 0.03)
55.Secondary Outcome
Title Change in Waist-to-hip Ratio From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing waist-to-hip ratio.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 21 11
Median (Inter-Quartile Range)
Unit of Measure: waist cm : hip cm
0
(-0.01 to 0.02)
0.02
(-0.02 to 0.04)
56.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD4+CD38+HLA-DR+ data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 19 12
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD4+ expressing CD38+HLA-DR+
0.20
(-0.60 to 1.50)
-1.35
(-2.10 to -0.75)
57.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24
Hide Description Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD8+CD38+HLA-DR+ data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 19 12
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD8+ expressing CD38+HLA-DR+
0.60
(-0.60 to 3.00)
-0.95
(-2.10 to -0.40)
58.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD4+CD38+HLA-DR+ data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 13
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD4+ expressing CD38+HLA-DR+
-0.30
(-0.90 to 1.10)
-0.60
(-1.30 to 0.20)
59.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD8+CD38+HLA-DR+ data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 13
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD8+ expressing CD38+HLA-DR+
-0.40
(-1.55 to 0.85)
-0.20
(-1.80 to 0.90)
60.Secondary Outcome
Title Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD163+ adipose tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 20 12
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD163+ adipose tissue cells
-0.19
(-5.55 to 3.76)
0.87
(-2.52 to 2.75)
61.Secondary Outcome
Title Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD4+ lymphoid tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD4+ lymphoid tissue cells
1
(-5.2 to 3.7)
-7.8
(-12.3 to 2.1)
62.Secondary Outcome
Title Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD8+ lymphoid tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD8+ lymphoid tissue cells
-1.19
(-5.3 to 1.5)
3.9
(1.0 to 9.2)
63.Secondary Outcome
Title Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD163+ lymphoid tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD163+ lymphoid tissue cells
-0.13
(-0.81 to 0.81)
0.15
(-0.77 to 0.69)
64.Secondary Outcome
Title Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD68+ lymphoid tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD68+ lymphoid tissue cells
-0.02
(-0.48 to 0.49)
0.08
(-1.07 to 0.24)
65.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD38+HLA-DR+ on CD4+ lymphoid tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD38+HLA-DR+ on CD4+ cells
-0.33
(-2.55 to 0.87)
0.06
(-0.35 to 1.11)
66.Secondary Outcome
Title Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.
Hide Description Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.

Additionally, have non-missing CD38+HLA-DR+ on CD8+ lymphoid tissue data.

Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description:

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control

Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Percent of CD38+HLA-DR+ on CD8+ cells
0.13
(-3.95 to 0.63)
-0.22
(-0.72 to 0.48)
Time Frame From baseline to Week 48.
Adverse Event Reporting Description Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.
 
Arm/Group Title Arm A: Telmisartan Arm B: No Study Drug
Hide Arm/Group Description

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Participants received no study drug and will follow week 0-48 evaluation schedule.

Control

All-Cause Mortality
Arm A: Telmisartan Arm B: No Study Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Arm A: Telmisartan Arm B: No Study Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   3/29 (10.34%)   1/15 (6.67%) 
Cardiac disorders     
Angina unstable  1  0/29 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders     
Diarrhoea  1  1/29 (3.45%)  0/15 (0.00%) 
Infections and infestations     
Herpes zoster disseminated  1  1/29 (3.45%)  0/15 (0.00%) 
Investigations     
Hepatic enzyme increased  1  1/29 (3.45%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Telmisartan Arm B: No Study Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   24/29 (82.76%)   10/15 (66.67%) 
Eye disorders     
Eye pruritus  1  0/29 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders     
Abdominal pain  1  1/29 (3.45%)  1/15 (6.67%) 
Abdominal pain upper  1  0/29 (0.00%)  1/15 (6.67%) 
Anal fistula  1  0/29 (0.00%)  1/15 (6.67%) 
Anorectal swelling  1  0/29 (0.00%)  1/15 (6.67%) 
Gastrooesophageal reflux disease  1  0/29 (0.00%)  1/15 (6.67%) 
Nausea  1  3/29 (10.34%)  0/15 (0.00%) 
Perianal erythema  1  0/29 (0.00%)  1/15 (6.67%) 
Proctalgia  1  0/29 (0.00%)  1/15 (6.67%) 
Rectal discharge  1  0/29 (0.00%)  1/15 (6.67%) 
Vomiting  1  3/29 (10.34%)  0/15 (0.00%) 
General disorders     
Chest pain  1  0/29 (0.00%)  1/15 (6.67%) 
Chills  1  2/29 (6.90%)  0/15 (0.00%) 
Peripheral swelling  1  2/29 (6.90%)  0/15 (0.00%) 
Pyrexia  1  3/29 (10.34%)  0/15 (0.00%) 
Immune system disorders     
Seasonal allergy  1  0/29 (0.00%)  1/15 (6.67%) 
Infections and infestations     
Gastroenteritis shigella  1  2/29 (6.90%)  0/15 (0.00%) 
Perirectal abscess  1  0/29 (0.00%)  1/15 (6.67%) 
Pneumonia bacterial  1  2/29 (6.90%)  0/15 (0.00%) 
Urinary tract infection  1  0/29 (0.00%)  1/15 (6.67%) 
Investigations     
Alanine aminotransferase increased  1  4/29 (13.79%)  1/15 (6.67%) 
Aspartate aminotransferase increased  1  4/29 (13.79%)  3/15 (20.00%) 
Blood alkaline phosphatase increased  1  0/29 (0.00%)  1/15 (6.67%) 
Blood bilirubin increased  1  4/29 (13.79%)  2/15 (13.33%) 
Blood cholesterol increased  1  13/29 (44.83%)  4/15 (26.67%) 
Blood creatinine increased  1  2/29 (6.90%)  1/15 (6.67%) 
Blood glucose increased  1  4/29 (13.79%)  1/15 (6.67%) 
Blood magnesium decreased  1  2/29 (6.90%)  1/15 (6.67%) 
Blood phosphorus decreased  1  7/29 (24.14%)  3/15 (20.00%) 
Blood sodium decreased  1  7/29 (24.14%)  2/15 (13.33%) 
Low density lipoprotein increased  1  13/29 (44.83%)  4/15 (26.67%) 
Neutrophil count decreased  1  0/29 (0.00%)  1/15 (6.67%) 
Platelet count decreased  1  2/29 (6.90%)  0/15 (0.00%) 
Weight decreased  1  2/29 (6.90%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/29 (6.90%)  0/15 (0.00%) 
Pain in extremity  1  0/29 (0.00%)  1/15 (6.67%) 
Rotator cuff syndrome  1  0/29 (0.00%)  1/15 (6.67%) 
Nervous system disorders     
Headache  1  2/29 (6.90%)  0/15 (0.00%) 
Psychiatric disorders     
Anxiety  1  2/29 (6.90%)  0/15 (0.00%) 
Sleep disorder  1  2/29 (6.90%)  0/15 (0.00%) 
Renal and urinary disorders     
Dysuria  1  0/29 (0.00%)  1/15 (6.67%) 
Reproductive system and breast disorders     
Penile discharge  1  0/29 (0.00%)  1/15 (6.67%) 
Penile pain  1  0/29 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/29 (13.79%)  1/15 (6.67%) 
Oropharyngeal pain  1  1/29 (3.45%)  1/15 (6.67%) 
Rhinitis allergic  1  0/29 (0.00%)  1/15 (6.67%) 
Rhinorrhoea  1  2/29 (6.90%)  1/15 (6.67%) 
Sneezing  1  0/29 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Erythema  1  2/29 (6.90%)  0/15 (0.00%) 
Vascular disorders     
Peripheral arterial occlusive disease  1  0/29 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01928927    
Other Study ID Numbers: ACTG A5317
UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: August 22, 2013
First Posted: August 27, 2013
Results First Submitted: March 1, 2017
Results First Posted: April 12, 2017
Last Update Posted: June 30, 2020