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Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated

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: NCT01529749
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Felipe Garcia, Hospital Clinic of Barcelona

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: EFV/FTC/TDF + Losartan
Drug: EFV/FTC/TDF
Drug: FTC/TDF + MK-0518
Drug: FTC/TDF+MK-0518+Losartan
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description EFV/FTC/TDF: 600/200/245 mg, od, oral EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12. FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Period Title: Overall Study
Started 12 12 12 12
Completed 12 10 10 10
Not Completed 0 2 2 2
Reason Not Completed
Lost to Follow-up             0             1             1             0
Physician Decision             0             0             0             1
Withdrawal by Subject             0             1             1             0
Protocol Violation             0             0             0             1
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan Total
Hide Arm/Group Description EFV/FTC/TDF: 600/200/245 mg, od, oral EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12. FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12. Total of all reporting groups
Overall Number of Baseline Participants 12 10 10 10 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
40
(33 to 48)
43
(35 to 49)
43
(42 to 51)
35
(32 to 48)
41
(33 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
Female
1
   8.3%
2
  20.0%
0
   0.0%
0
   0.0%
3
   7.1%
Male
11
  91.7%
8
  80.0%
10
 100.0%
10
 100.0%
39
  92.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
12 10 10 10 42
1.Primary Outcome
Title Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Eligibility criteria were being older than 18 years, being on ART with a combined triple therapy regimen and having viral load under the limit of detection for at least the previous 48 weeks.
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Patients With Changes in the Levels of CRP in Different Groups.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Patients With Increased CD4 in Peripheral Blood.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
6.Secondary Outcome
Title Proportion of Patients With Increased CD4 in Lymphatic Tissue.
Hide Description [Not Specified]
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
7.Secondary Outcome
Title Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
12 10 10 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
8.Secondary Outcome
Title Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
Hide Description [Not Specified]
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
12 10 10 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
9.Secondary Outcome
Title Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: ratio
-0.03
(-0.2 to 0.3)
0.04
(-0.2 to 0.3)
0.36
(0.0 to 0.5)
0.37
(0.2 to 0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Carotid ultrasound was performed at baseline in 41 out the 42 patients. However, only 36 patients repeated the ultrasound at week 48, and were included in the analysis (9 in each randomised group).
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 9 9 9 9
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
11.Secondary Outcome
Title Proportion of Patients With Changes in Levels of Metalloproteinases
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
12.Secondary Outcome
Title Proportion of Patients With Changes in Levels of beta2-microglobulin.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
13.Secondary Outcome
Title Proportion of Patients With Changes in Levels of CSF Cells.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
14.Secondary Outcome
Title Proportion of Patients With Changes in Levels of Proteins.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
15.Secondary Outcome
Title Proportion of Patients With Improvement in Neuropsychological Test
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
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Time Frame up to 48 weeks
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[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Number
Unit of Measure: participants
6 6 3 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
17.Secondary Outcome
Title Changes in CD4 CD38+ HLADR+ (%)
Hide Description Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)
Time Frame 0, 48 weeks
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[Not Specified]
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description:
EFV/FTC/TDF: 600/200/245 mg, od, oral
EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
Overall Number of Participants Analyzed 12 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: percentage of CD4 T cells
2.3
(1.4 to 5.5)
4
(2.6 to 4.4)
1.8
(1 to 2.5)
2.2
(1.6 to 3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV/FTC/TDF, EFV/FTC/TDF + Losartan, FTC/TDF + MK-0518, FTC/TDF+MK-0518+Losartan
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Hide Arm/Group Description EFV/FTC/TDF: 600/200/245 mg, od, oral EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12. FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
All-Cause Mortality
EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EFV/FTC/TDF EFV/FTC/TDF + Losartan FTC/TDF + MK-0518 FTC/TDF+MK-0518+Losartan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/12 (50.00%)      6/10 (60.00%)      3/10 (30.00%)      6/10 (60.00%)    
Endocrine disorders         
Gynecomastia *  1/12 (8.33%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea *  0/12 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain *  0/12 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Hepatobiliary disorders         
Liver tests abonormalities   1/12 (8.33%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations         
Hepatitis C   0/12 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 2/10 (20.00%)  2
Sexual transmitted diseases   1/12 (8.33%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2
Musculoskeletal and connective tissue disorders         
Tendinitis *  1/12 (8.33%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Nervous system disorders         
Post lumbar puncture headache  [1]  1/12 (8.33%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Headache *  0/12 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders         
Asthenia *  0/12 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Dysthimia *  1/12 (8.33%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Insomnia *  0/12 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash   0/12 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders         
High Blood Pressure   0/12 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Post lumbar puncture headache
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: FELIPE GARCIA ALCAIDE
Organization: Hospital Clínic
Phone: 34619175783
EMail: FGARCIA@clinic.cat
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Responsible Party: Felipe Garcia, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01529749    
Other Study ID Numbers: HIV-IMMUNESARTAN
2011-002071-42 ( EudraCT Number )
First Submitted: February 8, 2012
First Posted: February 9, 2012
Results First Submitted: April 17, 2018
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019