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Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada (RECOMB)

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: NCT00324649
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : May 20, 2009
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1
Interventions Drug: Truvada
Drug: Zidovudine/lamivudine
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
Period Title: Overall Study
Started 39 41
Completed 37 36
Not Completed 2 5
Reason Not Completed
Adverse Event             1             4
Withdrawal by Subject             0             1
Noncompliance             1             0
Arm/Group Title Truvada Zidovudine/Lamivudine Total
Hide Arm/Group Description Truvada + NNRTI or PI. Zidovudine/lamivudine + NNRTI or PI. Total of all reporting groups
Overall Number of Baseline Participants 39 41 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 41 participants 80 participants
44  (10.6) 44  (7.4) 44  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
Female
11
  28.2%
4
   9.8%
15.0
Male
28
  71.8%
37
  90.2%
65.0
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
White 36 38 74
Black, of African heritage 1 2 3
Asian 1 0 1
Other 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 39 participants 41 participants 80 participants
39 41 80
HIV-1 RNA Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 41 participants 80 participants
< 50 copies/mL 38 39 77
50 to < 400 copies/mL 1 2 3
Cluster determinant 4 (CD4) cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 39 participants 41 participants 80 participants
655.0
(505.0 to 789.0)
504.0
(363.0 to 756.0)
600.5
(420.0 to 760.5)
Total limb fat   [1] 
Median (Full Range)
Unit of measure:  Grams (g)
Number Analyzed 39 participants 41 participants 80 participants
3565
(511 to 15932)
3589
(903 to 28155)
3589
(511 to 28155)
[1]
Measure Description: Measured using dual-energy x-ray absorptiometry (DEXA). Total limb fat is the sum of the left arm, right arm, left leg, and right leg.
Years on zidovudine (AZT)/lamivudine (3TC)  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 39 participants 41 participants 80 participants
5.8
(4.2 to 7.2)
6.2
(4.7 to 7.2)
5.9
(4.6 to 7.2)
1.Primary Outcome
Title Change From Baseline in Limb Fat at Week 48
Hide Description Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Number of participants analyzed is those with baseline and post-baseline DEXA data. Last post-baseline observation carried forward (LOCF) method was used if the Week 48 limb fat value was missing.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 38 38
Median (Inter-Quartile Range)
Unit of Measure: grams (g)
392
(-102 to 1056)
-257
(-751 to 148)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
2.Secondary Outcome
Title Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 34 35
Median (Inter-Quartile Range)
Unit of Measure: Ratio
62.0
(20.0 to 212.0)
97.0
(20.0 to 197.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9713
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
3.Secondary Outcome
Title Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 36 35
Median (Inter-Quartile Range)
Unit of Measure: Ratio
36.0
(2.0 to 89.5)
43.0
(1.0 to 72.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9725
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
4.Secondary Outcome
Title Change From Baseline in Lactate Concentration
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 27 30
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
-0.23
(-0.55 to 0.00)
0.09
(-0.12 to 0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
5.Secondary Outcome
Title Percentage of Days for Which Participants Were Compliant With Study Drug
Hide Description Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated.
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 39 41
Median (Inter-Quartile Range)
Unit of Measure: Percentage of days with compliance
100.0
(99.8 to 100.0)
100.0
(99.6 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6984
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
6.Secondary Outcome
Title Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were treated as failure (i.e., as HIV-1 RNA greater than or equal to 50 copies/mL).
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of participants
92.3 78.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments

Null Hypothesis: treatment is not associated with the observed virologic response.

Alternative Hypothesis: treatment is associated with the observed virologic response.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1165
Comments No adjustments for multiple comparisons were made.
Method Fisher Exact
Comments No adjustments were made.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 14.3
Confidence Interval 95%
-0.9 to 29.4
Estimation Comments The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of participants
0 5
8.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
9.Secondary Outcome
Title Change From Baseline in Cluster Determinant 4 (CD4) Cell Count
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 36 34
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
60.5
(-6.5 to 159.0)
9.0
(-61.0 to 106.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0789
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
10.Secondary Outcome
Title Change From Baseline in Fasting Serum Triglycerides
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 34 31
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
1.5
(-31.0 to 17.0)
4.0
(-44.0 to 40.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9633
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
11.Secondary Outcome
Title Change From Baseline in Fasting Total Cholesterol
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 34 31
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
4.5
(-12.0 to 12.0)
1.0
(-19.0 to 21.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9686
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
12.Secondary Outcome
Title Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
7.0
(-9.4 to 15.6)
5.0
(-14.0 to 16.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6638
Comments No adjustments for multiple comparisons were performed.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
13.Secondary Outcome
Title Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 31 28
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
-2.0
(-7.0 to 2.0)
2.0
(-7.0 to 7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2907
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
14.Secondary Outcome
Title Change From Baseline in Hemoglobin
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 36 33
Median (Inter-Quartile Range)
Unit of Measure: g/dL
0.9
(0.0 to 1.2)
0.3
(-0.5 to 0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0072
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
15.Secondary Outcome
Title Percent Change From Baseline in Hematocrit
Hide Description Change = Week 48 value minus baseline value expressed as median percent change.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 36 33
Median (Inter-Quartile Range)
Unit of Measure: Percent change in hematocrit
2.7
(1.5 to 4.3)
1.0
(-0.9 to 2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
16.Secondary Outcome
Title Change From Baseline in Waist Circumference/Hip Circumference Ratio
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants. Missing values were excluded. Assessment of waist and hip circumference was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 28 25
Median (Inter-Quartile Range)
Unit of Measure: Ratio
-0.01
(-0.03 to 0.02)
0.01
(-0.01 to 0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Zidovudine/Lamivudine
Comments Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1785
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
17.Secondary Outcome
Title Percentage of Participants With Any Adverse Event
Hide Description

Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.

Treatment-emergent adverse events were events that met one of the following criteria:

  • Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.
  • Had no recorded start date.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of participants
77 85
18.Secondary Outcome
Title Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants.
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Zidovudine/lamivudine + NNRTI or PI.
Overall Number of Participants Analyzed 39 41
Measure Type: Number
Unit of Measure: Percentage of participants
3 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Truvada Zidovudine/Lamivudine
Hide Arm/Group Description Truvada + NNRTI or PI. Zidovudine/lamivudine + NNRTI or PI.
All-Cause Mortality
Truvada Zidovudine/Lamivudine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Truvada Zidovudine/Lamivudine
Affected / at Risk (%) Affected / at Risk (%)
Total   4   3 
Cardiac disorders     
Acute myocardial infarction * 1  0/39 (0.00%)  1/41 (2.44%) 
Prinzmetal angina *  0/39 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders     
Diarrhoea *  1/39 (2.56%)  0/41 (0.00%) 
Infections and infestations     
Respiratory tract infection *  0/39 (0.00%)  1/41 (2.44%) 
Injury, poisoning and procedural complications     
Lumbar vertebral fracture *  1/39 (2.56%)  0/41 (0.00%) 
Radius fracture *  0/39 (0.00%)  1/41 (2.44%) 
Nervous system disorders     
Cauda equina syndrome *  1/39 (2.56%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm *  0/39 (0.00%)  1/41 (2.44%) 
Emphysema *  1/39 (2.56%)  0/41 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Truvada Zidovudine/Lamivudine
Affected / at Risk (%) Affected / at Risk (%)
Total   24   28 
Blood and lymphatic system disorders     
Anaemia  1  1/39 (2.56%)  3/41 (7.32%) 
Neutropenia   0/39 (0.00%)  3/41 (7.32%) 
Gastrointestinal disorders     
Diarrhoea *  3/39 (7.69%)  2/41 (4.88%) 
Abdominal pain upper *  2/39 (5.13%)  0/41 (0.00%) 
General disorders     
Pyrexia *  2/39 (5.13%)  0/41 (0.00%) 
Infections and infestations     
Bronchitis *  2/39 (5.13%)  0/41 (0.00%) 
Investigations     
Gamma-glutamyltransferase increased   11/39 (28.21%)  10/41 (24.39%) 
Alanine aminotransferase increased   8/39 (20.51%)  10/41 (24.39%) 
Aspartate aminotransferase increased   4/39 (10.26%)  6/41 (14.63%) 
Blood amylase increased   4/39 (10.26%)  8/41 (19.51%) 
Lipase increased   1/39 (2.56%)  3/41 (7.32%) 
Blood creatine phosphokinase increased   3/39 (7.69%)  3/41 (7.32%) 
Blood lactic acid increased   2/39 (5.13%)  4/41 (9.76%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia   2/39 (5.13%)  4/41 (9.76%) 
Hyperlactacidaemia   2/39 (5.13%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain *  1/39 (2.56%)  3/41 (7.32%) 
Renal and urinary disorders     
Renal colic *  0/39 (0.00%)  3/41 (7.32%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pedro Ferrer
Organization: Gilead Sciences
Phone: +34 91 771 2478
EMail: pedro.ferrer@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00324649    
Other Study ID Numbers: GS-ES-164-0154
First Submitted: May 9, 2006
First Posted: May 11, 2006
Results First Submitted: March 30, 2009
Results First Posted: May 20, 2009
Last Update Posted: August 17, 2015