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TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada (TOTEM)

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ClinicalTrials.gov Identifier: NCT00323492
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : December 23, 2009
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Truvada
Drug: Current HAART regimen
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Truvada Maintain Baseline Regimen Delayed Truvada
Hide Arm/Group Description Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Maintain baseline regimen. Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).
Period Title: Study Phase 1
Started 47 45 0 [1]
Intent-to-Treat (ITT) Analysis Set 46 [2] 45 0
Completed 45 45 0
Not Completed 2 0 0
Reason Not Completed
Adverse Event             2             0             0
[1]
Not applicable to Phase 1.
[2]
One subject was excluded from ITT analysis set due to protocol violation.
Period Title: Study Phase 2
Started 44 [1] 18 [2] 25 [3]
Completed 40 17 24
Not Completed 4 1 1
Reason Not Completed
Adverse Event             1             0             0
Physician Decision             1             0             0
Lost to Follow-up             1             0             0
Withdrawal by Subject             0             1             0
Noncompliance with study schedule             0             0             1
Protocol Violation             1             0             0
[1]
1/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=46
[2]
2/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=20 (no switch to Truvada)
[3]
N=25 switched to Truvada in Phase 2.
Arm/Group Title Truvada Maintain Baseline Regimen Total
Hide Arm/Group Description Truvada + NNRTI or PI. Maintain baseline regimen. Total of all reporting groups
Overall Number of Baseline Participants 47 45 92
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants 45 participants 92 participants
49.0
(42.0 to 58.0)
43.0
(39.0 to 50.0)
47.0
(41.0 to 55.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 92 participants
Female
8
  17.0%
4
   8.9%
12
  13.0%
Male
39
  83.0%
41
  91.1%
80
  87.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 47 participants 45 participants 92 participants
47 45 92
Participants with plasma HIV-1 RNA < 400 copies/mL   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 92 participants
47 45 92
[1]
Measure Description: At screening
Cluster determinant 4 (CD4) cell count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 47 participants 45 participants 92 participants
467
(314 to 698)
559
(337 to 714)
528
(318 to 709)
[1]
Measure Description: At screening
Low density lipoprotein cholesterol (LDL-CHO)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mmol/L
Number Analyzed 47 participants 45 participants 92 participants
4.0
(3.2 to 4.7)
4.0
(3.6 to 4.8)
4.0
(3.4 to 4.7)
[1]
Measure Description: Centralized laboratory assessment
Triglycerides   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mmol/L
Number Analyzed 47 participants 45 participants 92 participants
2.3
(1.9 to 4.0)
2.7
(1.9 to 3.6)
2.4
(1.9 to 3.7)
[1]
Measure Description: Centralized laboratory assessment
1.Primary Outcome
Title Change From Baseline to Week 12 in Fasting Triglycerides
Hide Description Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 45
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
-0.5
(-1.2 to 0.0)
-0.1
(-0.8 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.034
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were applied.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.42
Confidence Interval 95%
-0.86 to -0.03
Estimation Comments Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.
2.Primary Outcome
Title Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)
Hide Description Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 45
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
-0.4
(-1.0 to 0.1)
-0.1
(-0.5 to 0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.031
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum text
Comments No adjustments were made.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.36
Confidence Interval 95%
-0.67 to -0.03
Estimation Comments Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.
3.Secondary Outcome
Title Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)
Hide Description Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
-0.1
(-0.2 to 0.1)
0.0
(0.0 to 0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.009
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.10
Confidence Interval 95%
-0.18 to -0.02
Estimation Comments Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.
4.Secondary Outcome
Title Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)
Hide Description Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
-0.8
(-1.3 to -0.1)
-0.1
(-0.7 to 0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 < 0.001
Comments No adjustments for multiple comparisons were made.
Method Wicoxon Rank Sum test
Comments no adjustments were made.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.64
Confidence Interval 95%
-1.01 to -0.27
Estimation Comments Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.
5.Secondary Outcome
Title Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO
Hide Description Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: Ratio
-0.5
(-0.7 to 0.2)
-0.1
(-0.8 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.51
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.10
Confidence Interval 95%
-0.44 to 0.19
Estimation Comments Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.
6.Secondary Outcome
Title Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO
Hide Description Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: Ratio
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.79
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.0
Confidence Interval 95%
-0.03 to 0.02
Estimation Comments Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.
7.Secondary Outcome
Title Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)
Hide Description Local laboratory assessment. Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded. Assessment of us-CRP 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 Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 16 7
Median (Inter-Quartile Range)
Unit of Measure: mg/L
0.4
(-0.5 to 0.9)
0.7
(-3.2 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.86
Comments No adjustments for multiple comparisons were made.
Method Wilcoxon Rank Sum test
Comments No adjustments were made.
8.Secondary Outcome
Title Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12
Hide Description Centralized laboratory assessment
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 44
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
9.Secondary Outcome
Title Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count
Hide Description Change = Week 12 value minus baseline value.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
17.5
(-36.0 to 63.5)
16.0
(-31.0 to 92.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 0.65
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 to Week 48 in CD4 Cell Count
Hide Description Change = Week 48 value minus baseline value.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 39 16
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
35.0
(-37.0 to 116.0)
40.0
(-41.5 to 79.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada
Comments Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments No adjustments were made.
Method Wilcoxon Signed Rank test
Comments No adjustments were made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintain Baseline Regimen
Comments Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments No adjustments were made.
Method Wilcoxon Signed Rank test
Comments No adjustments were made.
11.Secondary Outcome
Title Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were treated as failure.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: Percentage of participants
96 98
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada, Maintain Baseline Regimen
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 1.00
Comments No adjustments were made.
Method Fisher Exact
Comments No adjustments were made.
12.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were excluded. Any subjects with plasma HIV-1 RNA greater than or equal to 400 copies/mL at Week 12 were to have virologic genotyping performed.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
13.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Missing values were treated as failure.
Arm/Group Title Truvada Maintain Baseline Regimen
Hide Arm/Group Description:
Truvada + NNRTI or PI.
Maintain baseline regimen.
Overall Number of Participants Analyzed 46 20
Measure Type: Number
Unit of Measure: Percentage of participants
80 80
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Truvada Maintain Baseline Regimen All Truvada
Hide Arm/Group Description Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2). Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12). Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the "maintain baseline regimen" group in Study Phase 2).
All-Cause Mortality
Truvada Maintain Baseline Regimen All Truvada
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Truvada Maintain Baseline Regimen All Truvada
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/47 (14.89%)   3/45 (6.67%)   7/72 (9.72%) 
Gastrointestinal disorders       
Intestinal Obstruction *  1/47 (2.13%)  1/45 (2.22%)  1/72 (1.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostatic adenoma *  1/47 (2.13%)  0/45 (0.00%)  1/72 (1.39%) 
Nervous system disorders       
Sciatica *  0/47 (0.00%)  1/45 (2.22%)  0/72 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis * 1  1/47 (2.13%)  0/45 (0.00%)  1/72 (1.39%) 
Renal failure * 1  2/47 (4.26%)  0/45 (0.00%)  2/72 (2.78%) 
Renal impairment *  1/47 (2.13%)  0/45 (0.00%)  1/72 (1.39%) 
Tubulointerstitial Nephritis *  1/47 (2.13%)  0/45 (0.00%)  1/72 (1.39%) 
Respiratory, thoracic and mediastinal disorders       
Asthma *  1/47 (2.13%)  0/45 (0.00%)  1/72 (1.39%) 
Lung disorder *  0/47 (0.00%)  1/45 (2.22%)  0/72 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Truvada Maintain Baseline Regimen All Truvada
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/47 (31.91%)   6/45 (13.33%)   16/72 (22.22%) 
Gastrointestinal disorders       
Diarrhoea *  6/47 (12.77%)  2/45 (4.44%)  7/72 (9.72%) 
Abdominal pain *  3/47 (6.38%)  1/45 (2.22%)  3/72 (4.17%) 
Infections and infestations       
Bronchitis * 1  3/47 (6.38%)  2/45 (4.44%)  3/72 (4.17%) 
Herpes simplex *  3/47 (6.38%)  0/45 (0.00%)  3/72 (4.17%) 
Nasopharyngitis *  3/47 (6.38%)  0/45 (0.00%)  3/72 (4.17%) 
Musculoskeletal and connective tissue disorders       
Tendonitis *  3/47 (6.38%)  1/45 (2.22%)  3/72 (4.17%) 
Renal and urinary disorders       
Pollakiuria *  3/47 (6.38%)  0/45 (0.00%)  3/72 (4.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Comparison of adverse events between Truvada and maintain baseline regimen groups is inappropriate since numbers at risk (and exposure to study drug) are not balanced, as described in the adverse event treatment group descriptions.
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 Sciences, 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: results of the study in their entirety have been publicly disclosed by or with the consent of Gilead Sciences in an abstract, manuscript, or presentation form; or study has been completed at all study sites for at least 2 years.
Results Point of Contact
Name/Title: Camille Aubron-Olivier
Organization: Gilead Sciences
Phone: +33(0)1 42 737130
Responsible Party: Camille Aubron-Olivier, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00323492     History of Changes
Other Study ID Numbers: GS-FR-164-0109
First Submitted: May 5, 2006
First Posted: May 9, 2006
Results First Submitted: March 20, 2009
Results First Posted: December 23, 2009
Last Update Posted: January 20, 2010