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Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01106586
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : October 22, 2012
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Interventions Drug: Stribild
Drug: ATV
Drug: Ritonavir
Drug: FTC/TDF
Drug: Stribild Placebo
Drug: ATV Placebo
Drug: RTV Placebo
Drug: FTC/TDF Placebo
Enrollment 708
Recruitment Details Participants were enrolled at 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last study visit occurred on 18 September 2014.
Pre-assignment Details 1017 subjects were screened.
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Period Title: Overall Study
Started 353 355
Completed 68 70
Not Completed 285 285
Reason Not Completed
Adverse Event             9             15
Death             1             3
Pregnancy             2             2
Lack of Efficacy             1             0
Investigator's Discretion             5             8
Withdrew Consent             18             30
Lost to Follow-up             24             20
Participant Noncompliance             12             10
Protocol Violation             1             0
Participant Transferred to Another Study             212             197
Arm/Group Title Stribild ATV/r + FTC/TDF Total
Hide Arm/Group Description Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily Total of all reporting groups
Overall Number of Baseline Participants 353 355 708
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 353 participants 355 participants 708 participants
38  (10.5) 39  (9.8) 38  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Female
29
   8.2%
39
  11.0%
68
   9.6%
Male
324
  91.8%
316
  89.0%
640
  90.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
American Indian or Alaska Native 2 3 5
Asian 17 17 34
Black or African Heritage 72 47 119
Native Hawaiian or Pacific Islander 1 2 3
White 250 277 527
Other 11 9 20
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Portugal 1 2 3
United States 197 185 382
Thailand 7 4 11
Austria 12 8 20
United Kingdom 11 15 26
Switzerland 0 2 2
Italy 9 5 14
France 23 23 46
Mexico 3 2 5
Canada 19 22 41
Belgium 9 12 21
Australia 30 32 62
Denmark 1 2 3
Netherlands 2 4 6
Germany 29 36 65
Sweden 0 1 1
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Asymptomatic 285 293 578
Symptomatic HIV Infections 36 38 74
AIDS 32 24 56
Hepatitis B Virus (HBV) Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Negative 347 346 693
Positive 5 7 12
Indeterminate 0 1 1
Not done 1 1 2
Hepatitis C Virus (HCV) Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Negative 335 344 679
Positive 18 10 28
Indeterminate 0 0 0
Not done 0 1 1
HIV-1 RNA Category (copies/mL)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
≤ 100,000 copies/mL 203 214 417
> 100,000 copies/mL 150 141 291
CD4 Cell Count (/µL)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
≤ 50 μL 12 5 17
51 to ≤ 200 μL 42 34 76
201 to ≤ 350 μL 122 124 246
351 to ≤ 500 μL 122 122 244
> 500 μL 55 70 125
1.Primary Outcome
Title The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 353 355
Measure Type: Number
Unit of Measure: percentage of participants
89.5 86.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stribild, ATV/r + FTC/TDF
Comments The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA < 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA < 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 3.0
Confidence Interval (2-Sided) 95.2%
-1.9 to 7.8
Estimation Comments To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL).
2.Secondary Outcome
Title The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 353 355
Measure Type: Number
Unit of Measure: percentage of participants
83.3 82.3
3.Secondary Outcome
Title The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
Hide Description [Not Specified]
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 353 355
Measure Type: Number
Unit of Measure: percentage of participants
77.6 74.6
4.Secondary Outcome
Title The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192
Hide Description [Not Specified]
Time Frame Week 192
Hide Outcome Measure Data
Hide Analysis Population Description
Week 192 modified intent-to-treat (MITT) Analysis Set: 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 Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 74 78
Measure Type: Number
Unit of Measure: percentage of participants
78.4 73.1
5.Secondary Outcome
Title The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 353 355
Measure Type: Number
Unit of Measure: percentage of participants
86.1 84.8
6.Secondary Outcome
Title The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Hide Description Change = value of the relevant time point minus the baseline value
Time Frame Baseline; Weeks 48, 96, 144, and 192
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 353 355
Mean (Standard Deviation)
Unit of Measure: cells/µL
Change at Wk 48 (Stribild, n=334; ATV/r, n=321) 207  (164.2) 211  (160.3)
Change at Wk 96 (Stribild, n=317; ATV/r, n=315) 256  (166.8) 261  (188.0)
Change at Wk 144 (Stribild, n=297; ATV/r, n=286) 280  (159.8) 293  (211.5)
Change at Wk 192 (Stribild, n=69; ATV/r, n=72) 338  (186.8) 340  (224.2)
7.Secondary Outcome
Title The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 353 355
Measure Type: Number
Unit of Measure: percentage of participants
91.5 88.5
Time Frame Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
 
Arm/Group Title Stribild ATV/r + FTC/TDF
Hide Arm/Group Description Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
All-Cause Mortality
Stribild ATV/r + FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stribild ATV/r + FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   58/353 (16.43%)   62/355 (17.46%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  0/353 (0.00%)  1/355 (0.28%) 
Cardiac disorders     
Angina pectoris  1  0/353 (0.00%)  1/355 (0.28%) 
Myocardial infarction  1  1/353 (0.28%)  2/355 (0.56%) 
Congenital, familial and genetic disorders     
Congenital ureteric anomaly  1  1/353 (0.28%)  0/355 (0.00%) 
Eye disorders     
Iridocyclitis  1  0/353 (0.00%)  1/355 (0.28%) 
Gastrointestinal disorders     
Abdominal pain  1  1/353 (0.28%)  4/355 (1.13%) 
Colitis  1  1/353 (0.28%)  1/355 (0.28%) 
Constipation  1  1/353 (0.28%)  0/355 (0.00%) 
Diarrhoea  1  2/353 (0.57%)  0/355 (0.00%) 
Diverticulum  1  1/353 (0.28%)  0/355 (0.00%) 
Erosive oesophagitis  1  1/353 (0.28%)  0/355 (0.00%) 
Gastritis erosive  1  0/353 (0.00%)  1/355 (0.28%) 
Haemorrhoids  1  1/353 (0.28%)  0/355 (0.00%) 
Intestinal obstruction  1  0/353 (0.00%)  1/355 (0.28%) 
Large intestine perforation  1  0/353 (0.00%)  1/355 (0.28%) 
Lower gastrointestinal haemorrhage  1  0/353 (0.00%)  1/355 (0.28%) 
Pancreatitis  1  1/353 (0.28%)  0/355 (0.00%) 
Peptic ulcer haemorrhage  1  0/353 (0.00%)  1/355 (0.28%) 
Vomiting  1  0/353 (0.00%)  1/355 (0.28%) 
General disorders     
Asthenia  1  0/353 (0.00%)  1/355 (0.28%) 
Chest pain  1  1/353 (0.28%)  1/355 (0.28%) 
Pyrexia  1  1/353 (0.28%)  0/355 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  0/353 (0.00%)  1/355 (0.28%) 
Cholecystitis  1  0/353 (0.00%)  1/355 (0.28%) 
Immune system disorders     
Drug hypersensitivity  1  1/353 (0.28%)  0/355 (0.00%) 
Infections and infestations     
Abscess limb  1  0/353 (0.00%)  1/355 (0.28%) 
Abscess neck  1  0/353 (0.00%)  1/355 (0.28%) 
Anal abscess  1  1/353 (0.28%)  3/355 (0.85%) 
Appendicitis  1  3/353 (0.85%)  1/355 (0.28%) 
Appendicitis perforated  1  1/353 (0.28%)  0/355 (0.00%) 
Arthritis infective  1  1/353 (0.28%)  0/355 (0.00%) 
Breast abscess  1  1/353 (0.28%)  0/355 (0.00%) 
Bronchitis  1  1/353 (0.28%)  0/355 (0.00%) 
Bronchopneumonia  1  0/353 (0.00%)  1/355 (0.28%) 
Cellulitis  1  1/353 (0.28%)  2/355 (0.56%) 
Device related infection  1  0/353 (0.00%)  1/355 (0.28%) 
Ear infection  1  0/353 (0.00%)  1/355 (0.28%) 
Epididymitis  1  0/353 (0.00%)  1/355 (0.28%) 
Gastroenteritis  1  0/353 (0.00%)  1/355 (0.28%) 
Gastroenteritis cryptosporidial  1  1/353 (0.28%)  0/355 (0.00%) 
Gastrointestinal infection  1  0/353 (0.00%)  1/355 (0.28%) 
Herpes zoster oticus  1  0/353 (0.00%)  1/355 (0.28%) 
Impetigo  1  0/353 (0.00%)  1/355 (0.28%) 
Incision site infection  1  0/353 (0.00%)  1/355 (0.28%) 
Infectious colitis  1  1/353 (0.28%)  0/355 (0.00%) 
Influenza  1  1/353 (0.28%)  0/355 (0.00%) 
Lymphogranuloma venereum  1  1/353 (0.28%)  0/355 (0.00%) 
Malaria  1  1/353 (0.28%)  0/355 (0.00%) 
Malignant syphilis  1  1/353 (0.28%)  0/355 (0.00%) 
Meningitis aseptic  1  0/353 (0.00%)  1/355 (0.28%) 
Meningitis enteroviral  1  0/353 (0.00%)  1/355 (0.28%) 
Meningitis viral  1  0/353 (0.00%)  1/355 (0.28%) 
Orchitis  1  0/353 (0.00%)  1/355 (0.28%) 
Osteomyelitis  1  1/353 (0.28%)  1/355 (0.28%) 
Peritonitis  1  2/353 (0.57%)  0/355 (0.00%) 
Pilonidal cyst  1  0/353 (0.00%)  1/355 (0.28%) 
Pneumocystis jirovecii pneumonia  1  0/353 (0.00%)  1/355 (0.28%) 
Pneumonia  1  1/353 (0.28%)  1/355 (0.28%) 
Pneumonia bacterial  1  1/353 (0.28%)  0/355 (0.00%) 
Pneumonia streptococcal  1  1/353 (0.28%)  0/355 (0.00%) 
Pyelonephritis acute  1  0/353 (0.00%)  1/355 (0.28%) 
Respiratory syncytial virus infection  1  1/353 (0.28%)  0/355 (0.00%) 
Salpingitis  1  1/353 (0.28%)  0/355 (0.00%) 
Scrotal abscess  1  0/353 (0.00%)  1/355 (0.28%) 
Secondary syphilis  1  1/353 (0.28%)  0/355 (0.00%) 
Septic shock  1  0/353 (0.00%)  2/355 (0.56%) 
Shigella infection  1  1/353 (0.28%)  0/355 (0.00%) 
Staphylococcal infection  1  1/353 (0.28%)  0/355 (0.00%) 
Tonsillitis  1  0/353 (0.00%)  1/355 (0.28%) 
Urinary tract infection  1  1/353 (0.28%)  0/355 (0.00%) 
Viral infection  1  1/353 (0.28%)  0/355 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/353 (0.28%)  0/355 (0.00%) 
Ankle fracture  1  0/353 (0.00%)  1/355 (0.28%) 
Clavicle fracture  1  1/353 (0.28%)  0/355 (0.00%) 
Femur fracture  1  1/353 (0.28%)  0/355 (0.00%) 
Hand fracture  1  0/353 (0.00%)  1/355 (0.28%) 
Lower limb fracture  1  0/353 (0.00%)  1/355 (0.28%) 
Lumbar vertebral fracture  1  1/353 (0.28%)  0/355 (0.00%) 
Muscle rupture  1  1/353 (0.28%)  0/355 (0.00%) 
Muscle strain  1  1/353 (0.28%)  0/355 (0.00%) 
Overdose  1  2/353 (0.57%)  1/355 (0.28%) 
Post concussion syndrome  1  1/353 (0.28%)  0/355 (0.00%) 
Post procedural haemorrhage  1  0/353 (0.00%)  1/355 (0.28%) 
Skull fractured base  1  1/353 (0.28%)  0/355 (0.00%) 
Toxicity to various agents  1  1/353 (0.28%)  2/355 (0.56%) 
Upper limb fracture  1  1/353 (0.28%)  1/355 (0.28%) 
Wrist fracture  1  0/353 (0.00%)  1/355 (0.28%) 
Investigations     
Blood creatine phosphokinase increased  1  0/353 (0.00%)  1/355 (0.28%) 
Metabolism and nutrition disorders     
Dehydration  1  0/353 (0.00%)  1/355 (0.28%) 
Hyperkalaemia  1  1/353 (0.28%)  0/355 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/353 (0.00%)  1/355 (0.28%) 
Arthritis reactive  1  1/353 (0.28%)  0/355 (0.00%) 
Foot deformity  1  0/353 (0.00%)  1/355 (0.28%) 
Intervertebral disc displacement  1  0/353 (0.00%)  1/355 (0.28%) 
Neck pain  1  0/353 (0.00%)  1/355 (0.28%) 
Pain in jaw  1  0/353 (0.00%)  1/355 (0.28%) 
Rhabdomyolysis  1  1/353 (0.28%)  1/355 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer  1  1/353 (0.28%)  1/355 (0.28%) 
Anal squamous cell carcinoma  1  1/353 (0.28%)  0/355 (0.00%) 
Anogenital warts  1  0/353 (0.00%)  1/355 (0.28%) 
B-cell lymphoma stage II  1  0/353 (0.00%)  1/355 (0.28%) 
Basal cell carcinoma  1  0/353 (0.00%)  1/355 (0.28%) 
Bladder cancer  1  1/353 (0.28%)  0/355 (0.00%) 
Bladder neoplasm  1  1/353 (0.28%)  0/355 (0.00%) 
Burkitt's lymphoma  1  1/353 (0.28%)  0/355 (0.00%) 
Hodgkin's disease  1  1/353 (0.28%)  1/355 (0.28%) 
Nervous system disorders     
Cervical radiculopathy  1  1/353 (0.28%)  0/355 (0.00%) 
Coma  1  0/353 (0.00%)  1/355 (0.28%) 
Convulsion  1  2/353 (0.57%)  0/355 (0.00%) 
Critical illness polyneuropathy  1  0/353 (0.00%)  1/355 (0.28%) 
Haemorrhage intracranial  1  1/353 (0.28%)  0/355 (0.00%) 
Headache  1  0/353 (0.00%)  1/355 (0.28%) 
Hypoaesthesia  1  0/353 (0.00%)  1/355 (0.28%) 
Syncope  1  1/353 (0.28%)  1/355 (0.28%) 
Tension headache  1  1/353 (0.28%)  0/355 (0.00%) 
Transient ischaemic attack  1  1/353 (0.28%)  0/355 (0.00%) 
VIIth nerve paralysis  1  0/353 (0.00%)  1/355 (0.28%) 
Psychiatric disorders     
Alcohol withdrawal syndrome  1  1/353 (0.28%)  1/355 (0.28%) 
Bipolar disorder  1  0/353 (0.00%)  1/355 (0.28%) 
Depressed mood  1  0/353 (0.00%)  1/355 (0.28%) 
Depression  1  3/353 (0.85%)  1/355 (0.28%) 
Depressive symptom  1  0/353 (0.00%)  1/355 (0.28%) 
Drug dependence  1  1/353 (0.28%)  0/355 (0.00%) 
Major depression  1  1/353 (0.28%)  0/355 (0.00%) 
Mania  1  0/353 (0.00%)  1/355 (0.28%) 
Post-traumatic stress disorder  1  1/353 (0.28%)  0/355 (0.00%) 
Schizophrenia  1  1/353 (0.28%)  2/355 (0.56%) 
Substance abuse  1  0/353 (0.00%)  1/355 (0.28%) 
Substance-induced psychotic disorder  1  1/353 (0.28%)  0/355 (0.00%) 
Suicidal ideation  1  2/353 (0.57%)  1/355 (0.28%) 
Suicide attempt  1  2/353 (0.57%)  2/355 (0.56%) 
Renal and urinary disorders     
Hydronephrosis  1  1/353 (0.28%)  0/355 (0.00%) 
Nephrolithiasis  1  1/353 (0.28%)  0/355 (0.00%) 
Renal colic  1  0/353 (0.00%)  1/355 (0.28%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/353 (0.28%)  1/355 (0.28%) 
Dyspnoea  1  1/353 (0.28%)  0/355 (0.00%) 
Pneumonia aspiration  1  1/353 (0.28%)  1/355 (0.28%) 
Respiratory depression  1  0/353 (0.00%)  1/355 (0.28%) 
Respiratory distress  1  0/353 (0.00%)  1/355 (0.28%) 
Tonsillar hypertrophy  1  1/353 (0.28%)  0/355 (0.00%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  0/353 (0.00%)  1/355 (0.28%) 
Psoriasis  1  0/353 (0.00%)  1/355 (0.28%) 
Social circumstances     
Treatment noncompliance  1  0/353 (0.00%)  1/355 (0.28%) 
Vascular disorders     
Orthostatic hypotension  1  0/353 (0.00%)  1/355 (0.28%) 
Peripheral embolism  1  1/353 (0.28%)  0/355 (0.00%) 
Thrombophlebitis  1  1/353 (0.28%)  0/355 (0.00%) 
Venous thrombosis limb  1  1/353 (0.28%)  0/355 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stribild ATV/r + FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   326/353 (92.35%)   326/355 (91.83%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  23/353 (6.52%)  16/355 (4.51%) 
Eye disorders     
Ocular icterus  1  2/353 (0.57%)  52/355 (14.65%) 
Gastrointestinal disorders     
Abdominal pain  1  25/353 (7.08%)  26/355 (7.32%) 
Constipation  1  20/353 (5.67%)  14/355 (3.94%) 
Diarrhoea  1  99/353 (28.05%)  121/355 (34.08%) 
Dyspepsia  1  13/353 (3.68%)  19/355 (5.35%) 
Flatulence  1  16/353 (4.53%)  32/355 (9.01%) 
Nausea  1  80/353 (22.66%)  78/355 (21.97%) 
Vomiting  1  26/353 (7.37%)  35/355 (9.86%) 
General disorders     
Fatigue  1  60/353 (17.00%)  60/355 (16.90%) 
Pyrexia  1  23/353 (6.52%)  22/355 (6.20%) 
Hepatobiliary disorders     
Jaundice  1  0/353 (0.00%)  34/355 (9.58%) 
Immune system disorders     
Seasonal allergy  1  17/353 (4.82%)  19/355 (5.35%) 
Infections and infestations     
Bronchitis  1  47/353 (13.31%)  42/355 (11.83%) 
Chlamydial infection  1  18/353 (5.10%)  17/355 (4.79%) 
Folliculitis  1  19/353 (5.38%)  22/355 (6.20%) 
Gastroenteritis  1  18/353 (5.10%)  28/355 (7.89%) 
Herpes zoster  1  15/353 (4.25%)  20/355 (5.63%) 
Influenza  1  31/353 (8.78%)  24/355 (6.76%) 
Nasopharyngitis  1  53/353 (15.01%)  57/355 (16.06%) 
Onychomycosis  1  21/353 (5.95%)  13/355 (3.66%) 
Pharyngitis  1  23/353 (6.52%)  18/355 (5.07%) 
Sinusitis  1  35/353 (9.92%)  38/355 (10.70%) 
Syphilis  1  27/353 (7.65%)  29/355 (8.17%) 
Upper respiratory tract infection  1  86/353 (24.36%)  97/355 (27.32%) 
Urinary tract infection  1  18/353 (5.10%)  20/355 (5.63%) 
Metabolism and nutrition disorders     
Decreased appetite  1  14/353 (3.97%)  19/355 (5.35%) 
Vitamin D deficiency  1  21/353 (5.95%)  19/355 (5.35%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  35/353 (9.92%)  32/355 (9.01%) 
Back pain  1  46/353 (13.03%)  37/355 (10.42%) 
Pain in extremity  1  22/353 (6.23%)  21/355 (5.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anorectal human papilloma virus infection  1  21/353 (5.95%)  12/355 (3.38%) 
Nervous system disorders     
Dizziness  1  25/353 (7.08%)  28/355 (7.89%) 
Headache  1  67/353 (18.98%)  55/355 (15.49%) 
Paraesthesia  1  9/353 (2.55%)  21/355 (5.92%) 
Psychiatric disorders     
Anxiety  1  22/353 (6.23%)  29/355 (8.17%) 
Depression  1  47/353 (13.31%)  52/355 (14.65%) 
Insomnia  1  37/353 (10.48%)  36/355 (10.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  38/353 (10.76%)  46/355 (12.96%) 
Oropharyngeal pain  1  19/353 (5.38%)  32/355 (9.01%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  10/353 (2.83%)  18/355 (5.07%) 
Rash  1  30/353 (8.50%)  37/355 (10.42%) 
Vascular disorders     
Hypertension  1  24/353 (6.80%)  12/355 (3.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
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
Publications of Results:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01106586     History of Changes
Other Study ID Numbers: GS-US-236-0103
First Submitted: April 14, 2010
First Posted: April 20, 2010
Results First Submitted: September 20, 2012
Results First Posted: October 22, 2012
Last Update Posted: November 11, 2015