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Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT00892437
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : October 28, 2014
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: COBI
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI placebo
Drug: RTV placebo
Enrollment 85
Recruitment Details Participants were enrolled and treated in 32 study centers in the United States. The first participant was screened on 04 May 2009, and the last study visit occurred on 15 January 2015.
Pre-assignment Details 137 participants were screened.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description

Randomized Phase: Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Period Title: Randomized Phase
Started 56 29
Randomized and Treated 50 29
Completed 45 24
Not Completed 11 5
Reason Not Completed
Randomized but not treated             6             0
Adverse Event             2             2
Lost to Follow-up             1             3
Investigator’s Discretion             1             0
Withdrew Consent             1             0
Period Title: Open-Label Extension Phase
Started 44 [1] 19 [2]
Completed 32 15
Not Completed 12 4
Reason Not Completed
Adverse Event             4             2
Lack of Efficacy             1             0
Lost to Follow-up             3             1
Investigator's Discretion             1             0
Withdrew Consent             3             1
[1]
1 participant completed the randomized phase but did not enter the open-label extension phase.
[2]
5 participants completed the randomized phase but did not enter the open-label extension phase.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF Total
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Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Total of all reporting groups
Overall Number of Baseline Participants 50 29 79
Hide Baseline Analysis Population Description
ITT Analysis Set: participants who were randomized and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 29 participants 79 participants
37  (9.6) 34  (10.1) 36  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
Female
3
   6.0%
4
  13.8%
7
   8.9%
Male
47
  94.0%
25
  86.2%
72
  91.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
Hispanic or Latino
7
  14.0%
5
  17.2%
12
  15.2%
Not Hispanic or Latino
43
  86.0%
24
  82.8%
67
  84.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
Asian 0 2 2
Black 18 9 27
White 31 16 47
Other 1 2 3
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log_10 copies/mL
Number Analyzed 50 participants 29 participants 79 participants
4.56  (0.657) 4.69  (0.530) 4.61  (0.614)
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
≤ 100,000 copies/mL 38 18 56
> 100,000 copies/mL 12 11 23
Cluster of differentiation (CD4) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 50 participants 29 participants 79 participants
365  (201.3) 343  (178.1) 357  (192.2)
CD4 Cell Count Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
≤ 50 cells/μL 1 1 2
51 to ≤ 200 cells/μL 9 6 15
201 to ≤ 350 cells/μL 16 7 23
351 to ≤ 500 cells/μL 17 11 28
> 500 cells/μL 7 4 11
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
Asymptomatic 41 25 66
Symptomatic HIV Infections 1 1 2
AIDS 8 3 11
Chronic Hepatitis B Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
Negative 50 29 79
Positive 0 0 0
Chronic Hepatitis C Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 29 participants 79 participants
Negative 50 29 79
Positive 0 0 0
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: participants who were randomized and received at least one dose of study drug.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:

Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Overall Number of Participants Analyzed 50 29
Measure Type: Number
Unit of Measure: percentage of participants
84.0 89.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
Comments A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA < 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group – RTV group) in the response rate at Week 24 was greater than −12%.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -7.4
Confidence Interval (2-Sided) 95%
-24.6 to 9.9
Estimation Comments Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:

Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Overall Number of Participants Analyzed 50 29
Measure Type: Number
Unit of Measure: percentage of participants
82.0 89.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -8.3
Confidence Interval (2-Sided) 95%
-25.9 to 9.4
Estimation Comments Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.
3.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 24
Hide Description The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:

Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Overall Number of Participants Analyzed 46 27
Mean (Standard Deviation)
Unit of Measure: log_10 copies/mL
-2.80  (0.619) -2.97  (0.707)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean (LSM)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.25 to 0.22
Estimation Comments The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
4.Secondary Outcome
Title Change From Baseline in HIV-1 RNA at Week 48
Hide Description The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:

Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Overall Number of Participants Analyzed 46 27
Mean (Standard Deviation)
Unit of Measure: log_10 copies/mL
-2.79  (0.678) -2.96  (0.765)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.30 to 0.23
Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
5.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 24
Hide Description The change from baseline in CD4 cell count at Week 24 was analyzed.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:

Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Overall Number of Participants Analyzed 46 26
Mean (Standard Deviation)
Unit of Measure: cells/μL
200  (164.6) 202  (115.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 10
Confidence Interval (2-Sided) 95%
-63 to 84
Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
6.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description The change from baseline in CD4 cell count at Week 48 was analyzed.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:

Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Overall Number of Participants Analyzed 46 27
Mean (Standard Deviation)
Unit of Measure: cells/μL
243  (186.5) 213  (168.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 47
Confidence Interval (2-Sided) 95%
-41 to 134
Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
Time Frame Baseline through end of study (average of 169.9 weeks; maximum of 286 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF All ATV+COBI+FTC/TDF
Hide Arm/Group Description For the reporting of Adverse Events, this group includes participants who were randomized to receive COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily in the randomized phase, and were analyzed from Baseline to Week 60. For the reporting of Adverse Events, this group includes participants who were randomized to receive RTV 100 mg+COBI placebo+ATV 300 mg+FTC 200 mg/TDF 300 mg once daily in the randomized period, and were analyzed from Baseline to Week 60. The All ATV+COBI+FTC/TDF Safety Analysis Set included all participants who received at least 1 dose of COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind ATV+COBI+FTC/TDF group while they received double-blind ATV+COBI+FTC/TDF during the randomized phase and open-label ATV+COBI+FTC/TDF during the extension phase; adverse events collected from the open-label ATV+COBI+FTC/TDF extension phase only from the participants who were initially randomized to the ATV+RTV+FTC/TDF group during the randomized phase. Adverse event data collected up to Week 286 are presented in this entry.
All-Cause Mortality
ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF All ATV+COBI+FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF All ATV+COBI+FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/50 (4.00%)   2/29 (6.90%)   13/69 (18.84%) 
Cardiac disorders       
Pericarditis  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
General disorders       
Accidental death  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Hepatobiliary disorders       
Hepatitis alcoholic  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Jaundice  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Infections and infestations       
Appendicitis  1  0/50 (0.00%)  1/29 (3.45%)  0/69 (0.00%) 
Cellulitis  1  1/50 (2.00%)  0/29 (0.00%)  2/69 (2.90%) 
Meningitis  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Pneumonia  1  1/50 (2.00%)  1/29 (3.45%)  1/69 (1.45%) 
Injury, poisoning and procedural complications       
Laceration  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Overdose  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Road traffic accident  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer stage 0  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Nervous system disorders       
Altered state of consciousness  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Psychiatric disorders       
Suicide attempt  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Renal colic  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/50 (0.00%)  0/29 (0.00%)  1/69 (1.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF All ATV+COBI+FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/50 (68.00%)   23/29 (79.31%)   54/69 (78.26%) 
Eye disorders       
Ocular icterus  1  7/50 (14.00%)  4/29 (13.79%)  9/69 (13.04%) 
Gastrointestinal disorders       
Abdominal pain  1  2/50 (4.00%)  1/29 (3.45%)  6/69 (8.70%) 
Diarrhoea  1  5/50 (10.00%)  9/29 (31.03%)  11/69 (15.94%) 
Flatulence  1  0/50 (0.00%)  2/29 (6.90%)  0/69 (0.00%) 
Haemorrhoids  1  0/50 (0.00%)  2/29 (6.90%)  0/69 (0.00%) 
Nausea  1  5/50 (10.00%)  2/29 (6.90%)  10/69 (14.49%) 
General disorders       
Chest pain  1  3/50 (6.00%)  0/29 (0.00%)  5/69 (7.25%) 
Fatigue  1  4/50 (8.00%)  5/29 (17.24%)  8/69 (11.59%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  4/50 (8.00%)  0/29 (0.00%)  5/69 (7.25%) 
Jaundice  1  2/50 (4.00%)  2/29 (6.90%)  2/69 (2.90%) 
Infections and infestations       
Acute sinusitis  1  0/50 (0.00%)  2/29 (6.90%)  0/69 (0.00%) 
Bronchitis  1  4/50 (8.00%)  4/29 (13.79%)  13/69 (18.84%) 
Cellulitis  1  1/50 (2.00%)  0/29 (0.00%)  4/69 (5.80%) 
Folliculitis  1  1/50 (2.00%)  4/29 (13.79%)  2/69 (2.90%) 
Gonorrhoea  1  1/50 (2.00%)  1/29 (3.45%)  5/69 (7.25%) 
Influenza  1  0/50 (0.00%)  2/29 (6.90%)  5/69 (7.25%) 
Nasopharyngitis  1  0/50 (0.00%)  3/29 (10.34%)  5/69 (7.25%) 
Pharyngitis  1  2/50 (4.00%)  1/29 (3.45%)  4/69 (5.80%) 
Sinusitis  1  5/50 (10.00%)  3/29 (10.34%)  11/69 (15.94%) 
Syphilis  1  2/50 (4.00%)  1/29 (3.45%)  6/69 (8.70%) 
Upper respiratory tract infection  1  6/50 (12.00%)  2/29 (6.90%)  11/69 (15.94%) 
Investigations       
Weight increased  1  0/50 (0.00%)  2/29 (6.90%)  1/69 (1.45%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/50 (8.00%)  0/29 (0.00%)  7/69 (10.14%) 
Back pain  1  1/50 (2.00%)  2/29 (6.90%)  3/69 (4.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts  1  2/50 (4.00%)  1/29 (3.45%)  6/69 (8.70%) 
Nervous system disorders       
Dizziness  1  2/50 (4.00%)  3/29 (10.34%)  5/69 (7.25%) 
Headache  1  3/50 (6.00%)  0/29 (0.00%)  8/69 (11.59%) 
Sinus headache  1  3/50 (6.00%)  0/29 (0.00%)  3/69 (4.35%) 
Psychiatric disorders       
Anxiety  1  3/50 (6.00%)  3/29 (10.34%)  8/69 (11.59%) 
Depression  1  5/50 (10.00%)  4/29 (13.79%)  9/69 (13.04%) 
Insomnia  1  5/50 (10.00%)  2/29 (6.90%)  11/69 (15.94%) 
Renal and urinary disorders       
Nephrolithiasis  1  3/50 (6.00%)  0/29 (0.00%)  5/69 (7.25%) 
Reproductive system and breast disorders       
Erectile dysfunction  1  4/50 (8.00%)  0/29 (0.00%)  5/69 (7.25%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  6/50 (12.00%)  2/29 (6.90%)  10/69 (14.49%) 
Rhinitis allergic  1  1/50 (2.00%)  2/29 (6.90%)  1/69 (1.45%) 
Sinus congestion  1  3/50 (6.00%)  0/29 (0.00%)  5/69 (7.25%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  3/50 (6.00%)  0/29 (0.00%)  4/69 (5.80%) 
Rash  1  1/50 (2.00%)  2/29 (6.90%)  5/69 (7.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
There were no limitations affecting the analysis or results.
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 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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00892437     History of Changes
Other Study ID Numbers: GS-US-216-0105
First Submitted: April 30, 2009
First Posted: May 4, 2009
Results First Submitted: October 23, 2014
Results First Posted: October 28, 2014
Last Update Posted: February 15, 2016