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Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01108510
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 28, 2014
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Interventions Drug: COBI
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI placebo
Drug: RTV placebo
Enrollment 698
Recruitment Details Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The last study visit occurred on 17 April 2015.
Pre-assignment Details 867 participants were screened.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Period Title: Overall Study
Started 349 349
Completed 70 81
Not Completed 279 268
Reason Not Completed
Randomized but Not Treated             5             1
Joined Another Gilead-sponsored Study             186             195
Adverse Event             26             19
Lost to Follow-up             20             17
Withdrew Consent             21             15
Investigator’s Discretion             12             10
Participant Noncompliance             5             7
Lack of Efficacy             3             0
Pregnancy             0             3
Death             1             1
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF Total
Hide Arm/Group Description COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily Total of all reporting groups
Overall Number of Baseline Participants 344 348 692
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least on dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 344 participants 348 participants 692 participants
37  (9.8) 38  (9.6) 37  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
Female
57
  16.6%
61
  17.5%
118
  17.1%
Male
287
  83.4%
287
  82.5%
574
  82.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
Hispanic or Latino
97
  28.2%
92
  26.4%
189
  27.3%
Not Hispanic or Latino
245
  71.2%
253
  72.7%
498
  72.0%
Unknown or Not Reported
2
   0.6%
3
   0.9%
5
   0.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
American Indian or Alaska Native 1 2 3
Asian 44 37 81
Black or African Heritage 65 63 128
Native Hawaiian or Pacific Islander 1 1 2
White 198 215 413
Not Permitted 2 3 5
Other 33 27 60
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
Australia 7 8 15
Austria 13 5 18
Belgium 7 11 18
Brazil 18 17 35
Canada 26 18 44
Denmark 0 2 2
Dominican Republic 27 31 58
France 12 19 31
Germany 17 21 38
Italy 6 15 21
Mexico 18 17 35
Netherlands 0 1 1
Portugal 9 5 14
Spain 3 4 7
Switzerland 3 12 15
Thailand 35 31 66
United Kingdom 14 18 32
United States 134 114 248
[1]
Measure Description: All randomized participants were analyzed for Region of Enrollment (n = 349 per group)
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 344 participants 348 participants 692 participants
4.81  (0.585) 4.84  (0.594) 4.83  (0.589)
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
≤ 100,000 copies/mL 212 205 417
> 100,000 copies/mL 132 143 275
Cluster of differentiation (CD4) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 344 participants 348 participants 692 participants
353  (170.5) 351  (175.5) 352  (172.9)
CD4 Cell Count Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
≤ 50 cells/μL 11 12 23
51 to ≤ 200 cells/μL 49 45 94
201 to ≤ 350 cells/μL 114 126 240
351 to ≤ 500 cells/μL 123 117 240
> 500 cells/μL 47 48 95
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
Asymptomatic 285 292 577
Symptomatic HIV Infections 31 32 63
AIDS 28 24 52
Hepatitis B Surface Antigen Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
Positive 16 9 25
Negative 328 339 667
Hepatitis C Antibody Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 344 participants 348 participants 692 participants
Positive 21 16 37
Negative 323 331 654
Indeterminate 0 1 1
1.Primary 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 snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (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:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 344 348
Measure Type: Number
Unit of Measure: percentage of participants
85.2 87.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV+COBI+FTC/TDF, ATV+RTV+FTC/TDF
Comments 700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was > -12%.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -2.2
Confidence Interval (2-Sided) 95.2%
-7.4 to 3.0
Estimation Comments Difference in percentages of success and its 95.2% 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 96
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Time Frame Week 96
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:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 344 348
Measure Type: Number
Unit of Measure: percentage of participants
77.9 79.3
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 -1.4
Confidence Interval (2-Sided) 95%
-7.6 to 4.7
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 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Time Frame Week 144
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:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 344 348
Measure Type: Number
Unit of Measure: percentage of participants
72.1 74.1
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 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 -2.1
Confidence Interval (2-Sided) 95%
-8.7 to 4.5
Estimation Comments Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Time Frame Week 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 74 69
Measure Type: Number
Unit of Measure: percentage of participants
71.6 79.7
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 -8.0
Confidence Interval (2-Sided) 95%
-22.2 to 6.3
Estimation Comments Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.
5.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
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:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 313 324
Mean (Standard Deviation)
Unit of Measure: cells/μL
213  (151.0) 219  (150.4)
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 0.67
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 -5
Confidence Interval (2-Sided) 95%
-28 to 18
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 96
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 300 311
Mean (Standard Deviation)
Unit of Measure: cells/μL
277  (176.8) 287  (181.5)
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 0.51
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%
-38 to 19
Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
7.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 144
Hide Description [Not Specified]
Time Frame Baseline to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 275 288
Mean (Standard Deviation)
Unit of Measure: cells/μL
310  (188.0) 332  (199.8)
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 0.18
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 -22
Confidence Interval (2-Sided) 95%
-54 to 10
Estimation Comments The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.
8.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 192
Hide Description [Not Specified]
Time Frame Baseline to Week 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.
Arm/Group Title ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Hide Arm/Group Description:
COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Overall Number of Participants Analyzed 73 83
Mean (Standard Deviation)
Unit of Measure: cells/μL
350  (191.3) 343  (190.7)
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 Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
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 6
Confidence Interval (2-Sided) 95%
-55 to 67
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 drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days
Adverse Event Reporting Description Safety 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 COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
All-Cause Mortality
ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ATV+COBI+FTC/TDF ATV+RTV+FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   64/344 (18.60%)   50/348 (14.37%) 
Blood and lymphatic system disorders     
Anaemia  1  1/344 (0.29%)  1/348 (0.29%) 
Coagulopathy  1  1/344 (0.29%)  0/348 (0.00%) 
Leukocytosis  1  1/344 (0.29%)  0/348 (0.00%) 
Thrombocytopenia  1  1/344 (0.29%)  0/348 (0.00%) 
Cardiac disorders     
Arrhythmia  1  0/344 (0.00%)  1/348 (0.29%) 
Atrial tachycardia  1  1/344 (0.29%)  0/348 (0.00%) 
Bradycardia  1  0/344 (0.00%)  1/348 (0.29%) 
Palpitations  1  1/344 (0.29%)  1/348 (0.29%) 
Ear and labyrinth disorders     
Deafness unilateral  1  0/344 (0.00%)  1/348 (0.29%) 
Tinnitus  1  0/344 (0.00%)  1/348 (0.29%) 
Vertigo  1  0/344 (0.00%)  1/348 (0.29%) 
Gastrointestinal disorders     
Abdominal mass  1  1/344 (0.29%)  0/348 (0.00%) 
Abdominal pain  1  1/344 (0.29%)  0/348 (0.00%) 
Abdominal pain upper  1  1/344 (0.29%)  0/348 (0.00%) 
Colitis  1  2/344 (0.58%)  0/348 (0.00%) 
Crohn's disease  1  1/344 (0.29%)  0/348 (0.00%) 
Diarrhoea  1  1/344 (0.29%)  0/348 (0.00%) 
Enteritis  1  1/344 (0.29%)  0/348 (0.00%) 
Food poisoning  1  1/344 (0.29%)  0/348 (0.00%) 
Gastric ulcer  1  1/344 (0.29%)  0/348 (0.00%) 
Gastritis erosive  1  1/344 (0.29%)  0/348 (0.00%) 
Gastroduodenal ulcer  1  0/344 (0.00%)  1/348 (0.29%) 
Haematemesis  1  1/344 (0.29%)  0/348 (0.00%) 
Haematochezia  1  1/344 (0.29%)  0/348 (0.00%) 
Haemorrhoidal haemorrhage  1  1/344 (0.29%)  0/348 (0.00%) 
General disorders     
Chest pain  1  3/344 (0.87%)  3/348 (0.86%) 
General physical health deterioration  1  1/344 (0.29%)  0/348 (0.00%) 
Oedema peripheral  1  1/344 (0.29%)  0/348 (0.00%) 
Pyrexia  1  3/344 (0.87%)  3/348 (0.86%) 
Immune system disorders     
Immune reconstitution inflammatory syndrome  1  0/344 (0.00%)  1/348 (0.29%) 
Infections and infestations     
Abdominal wall abscess  1  1/344 (0.29%)  0/348 (0.00%) 
Abscess limb  1  1/344 (0.29%)  2/348 (0.57%) 
Abscess neck  1  1/344 (0.29%)  0/348 (0.00%) 
Anal abscess  1  1/344 (0.29%)  0/348 (0.00%) 
Appendicitis  1  0/344 (0.00%)  1/348 (0.29%) 
Appendicitis perforated  1  1/344 (0.29%)  0/348 (0.00%) 
Bacteraemia  1  1/344 (0.29%)  0/348 (0.00%) 
Bronchopneumonia  1  0/344 (0.00%)  1/348 (0.29%) 
Cellulitis  1  2/344 (0.58%)  2/348 (0.57%) 
Chancroid  1  1/344 (0.29%)  0/348 (0.00%) 
Dengue fever  1  1/344 (0.29%)  0/348 (0.00%) 
Diverticulitis  1  0/344 (0.00%)  1/348 (0.29%) 
Enterobacter sepsis  1  1/344 (0.29%)  0/348 (0.00%) 
Gastroenteritis  1  1/344 (0.29%)  3/348 (0.86%) 
Gastroenteritis salmonella  1  0/344 (0.00%)  1/348 (0.29%) 
Gastroenteritis shigella  1  0/344 (0.00%)  1/348 (0.29%) 
Genital abscess  1  0/344 (0.00%)  1/348 (0.29%) 
Gonorrhoea  1  1/344 (0.29%)  0/348 (0.00%) 
Groin abscess  1  1/344 (0.29%)  0/348 (0.00%) 
Herpes zoster  1  3/344 (0.87%)  0/348 (0.00%) 
Infected dermal cyst  1  0/344 (0.00%)  1/348 (0.29%) 
Infectious colitis  1  0/344 (0.00%)  1/348 (0.29%) 
Influenza  1  2/344 (0.58%)  0/348 (0.00%) 
Meningitis toxoplasmal  1  0/344 (0.00%)  1/348 (0.29%) 
Meningitis viral  1  1/344 (0.29%)  0/348 (0.00%) 
Oesophageal candidiasis  1  1/344 (0.29%)  0/348 (0.00%) 
Orchitis  1  1/344 (0.29%)  0/348 (0.00%) 
Osteomyelitis  1  0/344 (0.00%)  1/348 (0.29%) 
Osteomyelitis acute  1  0/344 (0.00%)  1/348 (0.29%) 
Otitis media chronic  1  1/344 (0.29%)  0/348 (0.00%) 
Perineal abscess  1  1/344 (0.29%)  0/348 (0.00%) 
Peritonitis  1  0/344 (0.00%)  1/348 (0.29%) 
Pharyngitis streptococcal  1  0/344 (0.00%)  1/348 (0.29%) 
Pneumocystis jirovecii pneumonia  1  1/344 (0.29%)  1/348 (0.29%) 
Pneumonia  1  2/344 (0.58%)  2/348 (0.57%) 
Pneumonia bacterial  1  0/344 (0.00%)  1/348 (0.29%) 
Pneumonia mycoplasmal  1  1/344 (0.29%)  0/348 (0.00%) 
Post procedural infection  1  1/344 (0.29%)  0/348 (0.00%) 
Pulmonary tuberculosis  1  1/344 (0.29%)  0/348 (0.00%) 
Pyelonephritis  1  1/344 (0.29%)  0/348 (0.00%) 
Scrotal abscess  1  1/344 (0.29%)  0/348 (0.00%) 
Sepsis  1  2/344 (0.58%)  2/348 (0.57%) 
Skin infection  1  1/344 (0.29%)  0/348 (0.00%) 
Subcutaneous abscess  1  4/344 (1.16%)  0/348 (0.00%) 
Tuberculosis  1  0/344 (0.00%)  1/348 (0.29%) 
Urinary tract infection  1  0/344 (0.00%)  1/348 (0.29%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/344 (0.29%)  0/348 (0.00%) 
Carbon monoxide poisoning  1  0/344 (0.00%)  1/348 (0.29%) 
Clavicle fracture  1  1/344 (0.29%)  0/348 (0.00%) 
Femur fracture  1  0/344 (0.00%)  1/348 (0.29%) 
Hand fracture  1  0/344 (0.00%)  1/348 (0.29%) 
Ligament rupture  1  1/344 (0.29%)  0/348 (0.00%) 
Lumbar vertebral fracture  1  0/344 (0.00%)  1/348 (0.29%) 
Overdose  1  0/344 (0.00%)  1/348 (0.29%) 
Renal haematoma  1  1/344 (0.29%)  0/348 (0.00%) 
Tendon rupture  1  0/344 (0.00%)  1/348 (0.29%) 
Thoracic vertebral fracture  1  0/344 (0.00%)  1/348 (0.29%) 
Upper limb fracture  1  1/344 (0.29%)  0/348 (0.00%) 
Wrist fracture  1  0/344 (0.00%)  1/348 (0.29%) 
Investigations     
Blood creatine phosphokinase increased  1  1/344 (0.29%)  0/348 (0.00%) 
Coma scale abnormal  1  1/344 (0.29%)  0/348 (0.00%) 
Gamma-glutamyltransferase increased  1  0/344 (0.00%)  1/348 (0.29%) 
Hepatic enzyme increased  1  1/344 (0.29%)  0/348 (0.00%) 
White blood cell count increased  1  1/344 (0.29%)  0/348 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/344 (0.29%)  1/348 (0.29%) 
Diabetes mellitus  1  2/344 (0.58%)  0/348 (0.00%) 
Diabetic ketoacidosis  1  0/344 (0.00%)  1/348 (0.29%) 
Hyperglycaemia  1  1/344 (0.29%)  0/348 (0.00%) 
Hypertriglyceridaemia  1  1/344 (0.29%)  0/348 (0.00%) 
Hypoglycaemia  1  0/344 (0.00%)  1/348 (0.29%) 
Malnutrition  1  1/344 (0.29%)  0/348 (0.00%) 
Metabolic acidosis  1  0/344 (0.00%)  1/348 (0.29%) 
Type 2 diabetes mellitus  1  0/344 (0.00%)  1/348 (0.29%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/344 (0.29%)  0/348 (0.00%) 
Muscular weakness  1  1/344 (0.29%)  0/348 (0.00%) 
Rhabdomyolysis  1  1/344 (0.29%)  0/348 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  1/344 (0.29%)  0/348 (0.00%) 
Burkitt's lymphoma  1  1/344 (0.29%)  0/348 (0.00%) 
Hodgkin's disease  1  0/344 (0.00%)  1/348 (0.29%) 
Uterine leiomyoma  1  1/344 (0.29%)  1/348 (0.29%) 
Nervous system disorders     
Ataxia  1  1/344 (0.29%)  0/348 (0.00%) 
Guillain-Barre syndrome  1  0/344 (0.00%)  1/348 (0.29%) 
Headache  1  1/344 (0.29%)  0/348 (0.00%) 
Migraine  1  1/344 (0.29%)  0/348 (0.00%) 
Subarachnoid haemorrhage  1  1/344 (0.29%)  0/348 (0.00%) 
Syncope  1  1/344 (0.29%)  0/348 (0.00%) 
Transient global amnesia  1  0/344 (0.00%)  1/348 (0.29%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  2/344 (0.58%)  1/348 (0.29%) 
Psychiatric disorders     
Alcohol withdrawal syndrome  1  1/344 (0.29%)  0/348 (0.00%) 
Alcoholism  1  0/344 (0.00%)  1/348 (0.29%) 
Anxiety disorder  1  0/344 (0.00%)  2/348 (0.57%) 
Confusional state  1  0/344 (0.00%)  1/348 (0.29%) 
Depression  1  3/344 (0.87%)  1/348 (0.29%) 
Drug dependence  1  2/344 (0.58%)  0/348 (0.00%) 
Post-traumatic stress disorder  1  1/344 (0.29%)  0/348 (0.00%) 
Schizophrenia  1  1/344 (0.29%)  0/348 (0.00%) 
Substance-induced psychotic disorder  1  1/344 (0.29%)  0/348 (0.00%) 
Suicidal ideation  1  1/344 (0.29%)  0/348 (0.00%) 
Suicide attempt  1  0/344 (0.00%)  1/348 (0.29%) 
Renal and urinary disorders     
Calculus ureteric  1  2/344 (0.58%)  2/348 (0.57%) 
Fanconi syndrome acquired  1  1/344 (0.29%)  1/348 (0.29%) 
Nephritis  1  0/344 (0.00%)  1/348 (0.29%) 
Nephrolithiasis  1  1/344 (0.29%)  0/348 (0.00%) 
Nephropathy  1  1/344 (0.29%)  0/348 (0.00%) 
Renal colic  1  1/344 (0.29%)  0/348 (0.00%) 
Renal failure  1  0/344 (0.00%)  1/348 (0.29%) 
Renal failure acute  1  1/344 (0.29%)  4/348 (1.15%) 
Renal tubular acidosis  1  0/344 (0.00%)  1/348 (0.29%) 
Renal tubular necrosis  1  0/344 (0.00%)  1/348 (0.29%) 
Reproductive system and breast disorders     
Cervical dysplasia  1  2/344 (0.58%)  1/348 (0.29%) 
Colpocele  1  0/344 (0.00%)  1/348 (0.29%) 
Ovarian cyst  1  1/344 (0.29%)  0/348 (0.00%) 
Priapism  1  0/344 (0.00%)  2/348 (0.57%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/344 (0.29%)  0/348 (0.00%) 
Chronic obstructive pulmonary disease  1  2/344 (0.58%)  0/348 (0.00%) 
Pneumonia aspiration  1  1/344 (0.29%)  0/348 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/344 (0.29%)  0/348 (0.00%) 
Rash  1  0/344 (0.00%)  1/348 (0.29%) 
Rash papular  1  1/344 (0.29%)  0/348 (0.00%) 
Skin abrasion  1  1/344 (0.29%)  0/348 (0.00%) 
Vasculitic rash  1  1/344 (0.29%)  0/348 (0.00%) 
Vascular disorders     
Hypovolaemic shock  1  0/344 (0.00%)  1/348 (0.29%) 
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
Affected / at Risk (%) Affected / at Risk (%)
Total   311/344 (90.41%)   312/348 (89.66%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  18/344 (5.23%)  26/348 (7.47%) 
Eye disorders     
Ocular icterus  1  69/344 (20.06%)  79/348 (22.70%) 
Gastrointestinal disorders     
Abdominal distension  1  16/344 (4.65%)  19/348 (5.46%) 
Abdominal pain  1  22/344 (6.40%)  26/348 (7.47%) 
Abdominal pain upper  1  19/344 (5.52%)  23/348 (6.61%) 
Diarrhoea  1  76/344 (22.09%)  96/348 (27.59%) 
Dyspepsia  1  15/344 (4.36%)  21/348 (6.03%) 
Flatulence  1  28/344 (8.14%)  10/348 (2.87%) 
Haemorrhoids  1  23/344 (6.69%)  21/348 (6.03%) 
Nausea  1  66/344 (19.19%)  66/348 (18.97%) 
Vomiting  1  34/344 (9.88%)  25/348 (7.18%) 
General disorders     
Fatigue  1  38/344 (11.05%)  34/348 (9.77%) 
Pyrexia  1  36/344 (10.47%)  30/348 (8.62%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  42/344 (12.21%)  39/348 (11.21%) 
Jaundice  1  76/344 (22.09%)  61/348 (17.53%) 
Infections and infestations     
Bronchitis  1  33/344 (9.59%)  33/348 (9.48%) 
Folliculitis  1  18/344 (5.23%)  7/348 (2.01%) 
Gastroenteritis  1  12/344 (3.49%)  20/348 (5.75%) 
Influenza  1  25/344 (7.27%)  19/348 (5.46%) 
Nasopharyngitis  1  59/344 (17.15%)  79/348 (22.70%) 
Oral candidiasis  1  21/344 (6.10%)  19/348 (5.46%) 
Pharyngitis  1  17/344 (4.94%)  27/348 (7.76%) 
Sinusitis  1  28/344 (8.14%)  28/348 (8.05%) 
Syphilis  1  23/344 (6.69%)  26/348 (7.47%) 
Tinea pedis  1  18/344 (5.23%)  11/348 (3.16%) 
Upper respiratory tract infection  1  67/344 (19.48%)  65/348 (18.68%) 
Urinary tract infection  1  25/344 (7.27%)  25/348 (7.18%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/344 (5.52%)  19/348 (5.46%) 
Back pain  1  34/344 (9.88%)  42/348 (12.07%) 
Myalgia  1  18/344 (5.23%)  20/348 (5.75%) 
Pain in extremity  1  18/344 (5.23%)  15/348 (4.31%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  24/344 (6.98%)  16/348 (4.60%) 
Nervous system disorders     
Dizziness  1  32/344 (9.30%)  28/348 (8.05%) 
Headache  1  57/344 (16.57%)  73/348 (20.98%) 
Psychiatric disorders     
Anxiety  1  19/344 (5.52%)  16/348 (4.60%) 
Depression  1  25/344 (7.27%)  28/348 (8.05%) 
Insomnia  1  26/344 (7.56%)  29/348 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  36/344 (10.47%)  29/348 (8.33%) 
Nasal congestion  1  15/344 (4.36%)  29/348 (8.33%) 
Oropharyngeal pain  1  20/344 (5.81%)  24/348 (6.90%) 
Skin and subcutaneous tissue disorders     
Rash  1  26/344 (7.56%)  31/348 (8.91%) 
Vascular disorders     
Hypertension  1  18/344 (5.23%)  23/348 (6.61%) 
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: NCT01108510     History of Changes
Other Study ID Numbers: GS-US-216-0114
2009-016759-22 ( EudraCT Number )
First Submitted: April 20, 2010
First Posted: April 22, 2010
Results First Submitted: October 23, 2014
Results First Posted: October 28, 2014
Last Update Posted: May 23, 2016