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

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ClinicalTrials.gov Identifier: NCT01095796
Recruitment Status : Completed
First Posted : March 30, 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: Atripla
Drug: Stribild Placebo
Drug: Atripla Placebo
Enrollment 707
Recruitment Details Participants were enrolled at sites in the United States and Puerto Rico. The first participant was screened on 16 March 2010. The last study visit occurred on 02 September 2014.
Pre-assignment Details 917 participants were screened.
Arm/Group Title Stribild Atripla
Hide Arm/Group Description Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Period Title: Overall Study
Started 353 354
Completed 58 65
Not Completed 295 289
Reason Not Completed
Randomized but Not Treated             5             2
Adverse Event             9             19
Death             3             2
Pregnancy             2             0
Lack of Efficacy             5             3
Investigator's Discretion             7             2
Withdrew Consent             16             22
Lost to Follow-up             27             29
Participant Noncompliance             5             10
Protocol Violation             1             0
Participant Transferred to Another Study             215             200
Arm/Group Title Stribild Atripla Total
Hide Arm/Group Description Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily Total of all reporting groups
Overall Number of Baseline Participants 348 352 700
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 348 participants 352 participants 700 participants
38  (10.4) 38  (10.6) 38  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
Female
41
  11.8%
36
  10.2%
77
  11.0%
Male
307
  88.2%
316
  89.8%
623
  89.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
American Indian or Alaska Native 2 4 6
Asian 6 10 16
Black or African Heritage 106 91 197
Native Hawaiian or Pacific Islander 4 1 5
White 214 227 441
Other 16 19 35
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 348 participants 352 participants 700 participants
348 352 700
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
Asymptomatic 290 295 585
Symptomatic HIV Infections 30 33 63
AIDS 28 24 52
Hepatitis B Virus (HBV) Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
Negative 343 343 686
Positive 5 9 14
Hepatitis C Virus (HCV) Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
Negative 331 337 668
Positive 17 15 32
HIV-1 RNA Category (copies/mL)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
≤ 100,000 230 236 466
> 100,000 118 116 234
CD4 Cell Count (/µL)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 348 participants 352 participants 700 participants
≤ 50 7 6 13
51 to ≤ 200 36 45 81
201 to ≤ 350 112 96 208
351 to ≤ 500 113 136 249
> 500 80 69 149
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
Intent-to-treat (ITT) Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title Stribild Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 348 352
Measure Type: Number
Unit of Measure: percentage of participants
87.6 84.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stribild, Atripla
Comments The null hypothesis was that the percentage of participants achieving HIV-1 RNA < 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla 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 3.6
Confidence Interval (2-Sided) 95.2%
-1.6 to 8.8
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: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title Stribild Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 348 352
Measure Type: Number
Unit of Measure: percentage of participants
84.2 81.5
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: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title Stribild Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 348 352
Measure Type: Number
Unit of Measure: percentage of participants
80.2 75.3
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 Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 71 73
Measure Type: Number
Unit of Measure: percentage of participants
76.1 78.1
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 Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 348 352
Measure Type: Number
Unit of Measure: percentage of participants
85.9 83.2
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 all participants with missing data were excluded from analysis.
Arm/Group Title Stribild Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 348 352
Mean (Standard Deviation)
Unit of Measure: cells/µL
Change at Wk 48 (Stribild, n=325; Atripla, n=315) 239  (167.2) 206  (153.4)
Change at Wk 96 (Stribild, n=307; Atripla, n=302) 295  (213.3) 273  (189.7)
Change at Wk 144 (Stribild, n=294; Atripla, n=283) 321  (227.0) 300  (202.3)
Change at Wk 192 (Stribild, n=62; Atripla, n=69) 360  (285.9) 328  (227.6)
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 Atripla
Hide Arm/Group Description:
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed 348 352
Measure Type: Number
Unit of Measure: percentage of participants
88.8 85.5
Time Frame Up to 218 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants were randomized and received at least one dose of study drug.
 
Arm/Group Title Stribild Atripla
Hide Arm/Group Description Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
All-Cause Mortality
Stribild Atripla
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stribild Atripla
Affected / at Risk (%) Affected / at Risk (%)
Total   69/348 (19.83%)   50/352 (14.20%) 
Blood and lymphatic system disorders     
Anaemia  1  0/348 (0.00%)  1/352 (0.28%) 
Antiphospholipid syndrome  1  0/348 (0.00%)  1/352 (0.28%) 
Splenic vein thrombosis  1  0/348 (0.00%)  1/352 (0.28%) 
Thrombocytopenia  1  0/348 (0.00%)  1/352 (0.28%) 
Cardiac disorders     
Acute myocardial infarction  1  0/348 (0.00%)  1/352 (0.28%) 
Bradycardia  1  0/348 (0.00%)  1/352 (0.28%) 
Intracardiac mass  1  0/348 (0.00%)  1/352 (0.28%) 
Palpitations  1  0/348 (0.00%)  1/352 (0.28%) 
Supraventricular tachycardia  1  0/348 (0.00%)  1/352 (0.28%) 
Tachycardia  1  0/348 (0.00%)  1/352 (0.28%) 
Gastrointestinal disorders     
Abdominal pain  1  1/348 (0.29%)  2/352 (0.57%) 
Colitis  1  2/348 (0.57%)  0/352 (0.00%) 
Diarrhoea  1  1/348 (0.29%)  0/352 (0.00%) 
Gastritis  1  1/348 (0.29%)  0/352 (0.00%) 
Haematemesis  1  1/348 (0.29%)  0/352 (0.00%) 
Inflammatory bowel disease  1  0/348 (0.00%)  1/352 (0.28%) 
Inguinal hernia  1  1/348 (0.29%)  0/352 (0.00%) 
Intestinal mass  1  1/348 (0.29%)  0/352 (0.00%) 
Intestinal perforation  1  1/348 (0.29%)  1/352 (0.28%) 
Mesenteric vein thrombosis  1  0/348 (0.00%)  1/352 (0.28%) 
Pancreatitis  1  1/348 (0.29%)  0/352 (0.00%) 
Pancreatitis acute  1  0/348 (0.00%)  1/352 (0.28%) 
Proctalgia  1  2/348 (0.57%)  0/352 (0.00%) 
Umbilical hernia  1  1/348 (0.29%)  0/352 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/348 (0.29%)  0/352 (0.00%) 
Vomiting  1  1/348 (0.29%)  0/352 (0.00%) 
General disorders     
Asthenia  1  0/348 (0.00%)  1/352 (0.28%) 
Chest pain  1  1/348 (0.29%)  1/352 (0.28%) 
Fatigue  1  2/348 (0.57%)  0/352 (0.00%) 
Non-cardiac chest pain  1  1/348 (0.29%)  0/352 (0.00%) 
Pyrexia  1  1/348 (0.29%)  2/352 (0.57%) 
Systemic inflammatory response syndrome  1  1/348 (0.29%)  0/352 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/348 (0.29%)  1/352 (0.28%) 
Cholelithiasis  1  2/348 (0.57%)  0/352 (0.00%) 
Hepatitis alcoholic  1  1/348 (0.29%)  0/352 (0.00%) 
Liver injury  1  1/348 (0.29%)  0/352 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/348 (0.00%)  1/352 (0.28%) 
Infections and infestations     
Abscess limb  1  1/348 (0.29%)  0/352 (0.00%) 
Acute sinusitis  1  0/348 (0.00%)  1/352 (0.28%) 
Appendicitis  1  4/348 (1.15%)  3/352 (0.85%) 
Bronchitis  1  1/348 (0.29%)  3/352 (0.85%) 
Bronchitis bacterial  1  1/348 (0.29%)  0/352 (0.00%) 
Cellulitis  1  6/348 (1.72%)  0/352 (0.00%) 
Cellulitis staphylococcal  1  1/348 (0.29%)  0/352 (0.00%) 
Diarrhoea infectious  1  0/348 (0.00%)  1/352 (0.28%) 
Diverticulitis  1  1/348 (0.29%)  1/352 (0.28%) 
Gastroenteritis  1  2/348 (0.57%)  1/352 (0.28%) 
Giardiasis  1  0/348 (0.00%)  1/352 (0.28%) 
H1N1 influenza  1  1/348 (0.29%)  0/352 (0.00%) 
Herpes simplex  1  1/348 (0.29%)  0/352 (0.00%) 
Incision site infection  1  1/348 (0.29%)  0/352 (0.00%) 
Meningitis viral  1  1/348 (0.29%)  0/352 (0.00%) 
Muscle abscess  1  1/348 (0.29%)  0/352 (0.00%) 
Neurosyphilis  1  1/348 (0.29%)  2/352 (0.57%) 
Ovarian abscess  1  1/348 (0.29%)  0/352 (0.00%) 
Pelvic inflammatory disease  1  1/348 (0.29%)  0/352 (0.00%) 
Pneumonia  1  9/348 (2.59%)  2/352 (0.57%) 
Pneumonia legionella  1  1/348 (0.29%)  0/352 (0.00%) 
Pulmonary tuberculosis  1  1/348 (0.29%)  0/352 (0.00%) 
Pyelonephritis acute  1  0/348 (0.00%)  1/352 (0.28%) 
Rectal abscess  1  1/348 (0.29%)  0/352 (0.00%) 
Secondary syphilis  1  1/348 (0.29%)  0/352 (0.00%) 
Sepsis  1  0/348 (0.00%)  1/352 (0.28%) 
Sepsis syndrome  1  0/348 (0.00%)  1/352 (0.28%) 
Skin bacterial infection  1  0/348 (0.00%)  1/352 (0.28%) 
Subcutaneous abscess  1  1/348 (0.29%)  0/352 (0.00%) 
Urinary tract infection  1  0/348 (0.00%)  1/352 (0.28%) 
Viral infection  1  3/348 (0.86%)  0/352 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Cervical vertebral fracture  1  0/348 (0.00%)  1/352 (0.28%) 
Facial bones fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Femur fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Fibula fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Gun shot wound  1  1/348 (0.29%)  0/352 (0.00%) 
Head injury  1  0/348 (0.00%)  1/352 (0.28%) 
Humerus fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Intentional overdose  1  1/348 (0.29%)  0/352 (0.00%) 
Joint dislocation  1  1/348 (0.29%)  0/352 (0.00%) 
Limb injury  1  0/348 (0.00%)  1/352 (0.28%) 
Lumbar vertebral fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Post procedural haemorrhage  1  1/348 (0.29%)  0/352 (0.00%) 
Subdural haematoma  1  1/348 (0.29%)  0/352 (0.00%) 
Tibia fracture  1  1/348 (0.29%)  0/352 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/348 (0.29%)  0/352 (0.00%) 
Aspartate aminotransferase increased  1  1/348 (0.29%)  0/352 (0.00%) 
Transaminases increased  1  1/348 (0.29%)  0/352 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/348 (0.00%)  2/352 (0.57%) 
Diabetic ketoacidosis  1  0/348 (0.00%)  1/352 (0.28%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/348 (0.00%)  1/352 (0.28%) 
Back pain  1  0/348 (0.00%)  1/352 (0.28%) 
Intervertebral disc protrusion  1  1/348 (0.29%)  0/352 (0.00%) 
Synovitis  1  1/348 (0.29%)  0/352 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/348 (0.00%)  1/352 (0.28%) 
Anal cancer  1  0/348 (0.00%)  1/352 (0.28%) 
Anal cancer recurrent  1  0/348 (0.00%)  1/352 (0.28%) 
Anorectal human papilloma virus infection  1  1/348 (0.29%)  0/352 (0.00%) 
Bladder cancer recurrent  1  1/348 (0.29%)  0/352 (0.00%) 
Burkitt's lymphoma  1  1/348 (0.29%)  0/352 (0.00%) 
Colorectal cancer stage IV  1  0/348 (0.00%)  1/352 (0.28%) 
Diffuse large B-cell lymphoma  1  0/348 (0.00%)  1/352 (0.28%) 
Hodgkin's disease  1  1/348 (0.29%)  0/352 (0.00%) 
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma  1  0/348 (0.00%)  1/352 (0.28%) 
Kaposi's sarcoma  1  1/348 (0.29%)  0/352 (0.00%) 
Lymphoma  1  1/348 (0.29%)  0/352 (0.00%) 
Malignant melanoma  1  0/348 (0.00%)  1/352 (0.28%) 
Metastatic neoplasm  1  0/348 (0.00%)  1/352 (0.28%) 
Uterine leiomyoma  1  2/348 (0.57%)  1/352 (0.28%) 
Nervous system disorders     
Convulsion  1  0/348 (0.00%)  1/352 (0.28%) 
Grand mal convulsion  1  0/348 (0.00%)  1/352 (0.28%) 
Headache  1  1/348 (0.29%)  1/352 (0.28%) 
Hepatic encephalopathy  1  1/348 (0.29%)  0/352 (0.00%) 
Migraine  1  1/348 (0.29%)  1/352 (0.28%) 
Presyncope  1  0/348 (0.00%)  1/352 (0.28%) 
Syncope  1  1/348 (0.29%)  2/352 (0.57%) 
Psychiatric disorders     
Alcoholism  1  1/348 (0.29%)  0/352 (0.00%) 
Bipolar disorder  1  1/348 (0.29%)  1/352 (0.28%) 
Completed suicide  1  1/348 (0.29%)  2/352 (0.57%) 
Depression  1  2/348 (0.57%)  1/352 (0.28%) 
Depression suicidal  1  1/348 (0.29%)  0/352 (0.00%) 
Drug dependence  1  0/348 (0.00%)  1/352 (0.28%) 
Major depression  1  0/348 (0.00%)  1/352 (0.28%) 
Psychotic disorder  1  0/348 (0.00%)  1/352 (0.28%) 
Suicidal behaviour  1  1/348 (0.29%)  0/352 (0.00%) 
Suicidal ideation  1  1/348 (0.29%)  0/352 (0.00%) 
Suicide attempt  1  1/348 (0.29%)  2/352 (0.57%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/348 (0.00%)  2/352 (0.57%) 
Renal failure  1  1/348 (0.29%)  0/352 (0.00%) 
Renal failure acute  1  0/348 (0.00%)  1/352 (0.28%) 
Reproductive system and breast disorders     
Pelvic pain  1  0/348 (0.00%)  1/352 (0.28%) 
Testicular mass  1  1/348 (0.29%)  0/352 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  3/348 (0.86%)  1/352 (0.28%) 
Chronic obstructive pulmonary disease  1  1/348 (0.29%)  0/352 (0.00%) 
Dyspnoea  1  0/348 (0.00%)  2/352 (0.57%) 
Dyspnoea exertional  1  0/348 (0.00%)  1/352 (0.28%) 
Pleural effusion  1  0/348 (0.00%)  1/352 (0.28%) 
Pneumomediastinum  1  0/348 (0.00%)  1/352 (0.28%) 
Pulmonary embolism  1  0/348 (0.00%)  1/352 (0.28%) 
Pulmonary thrombosis  1  1/348 (0.29%)  0/352 (0.00%) 
Respiratory failure  1  1/348 (0.29%)  0/352 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  0/348 (0.00%)  1/352 (0.28%) 
Social circumstances     
Alcohol use  1  1/348 (0.29%)  0/352 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  2/348 (0.57%)  0/352 (0.00%) 
Haematoma  1  0/348 (0.00%)  1/352 (0.28%) 
Hypertension  1  2/348 (0.57%)  0/352 (0.00%) 
Hypertensive crisis  1  1/348 (0.29%)  0/352 (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 Atripla
Affected / at Risk (%) Affected / at Risk (%)
Total   313/348 (89.94%)   326/352 (92.61%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  16/348 (4.60%)  18/352 (5.11%) 
Gastrointestinal disorders     
Abdominal pain  1  24/348 (6.90%)  18/352 (5.11%) 
Constipation  1  22/348 (6.32%)  14/352 (3.98%) 
Diarrhoea  1  93/348 (26.72%)  91/352 (25.85%) 
Dyspepsia  1  19/348 (5.46%)  10/352 (2.84%) 
Gastrooesophageal reflux disease  1  19/348 (5.46%)  14/352 (3.98%) 
Haemorrhoids  1  23/348 (6.61%)  13/352 (3.69%) 
Nausea  1  80/348 (22.99%)  59/352 (16.76%) 
Vomiting  1  28/348 (8.05%)  23/352 (6.53%) 
General disorders     
Fatigue  1  53/348 (15.23%)  61/352 (17.33%) 
Pyrexia  1  21/348 (6.03%)  23/352 (6.53%) 
Infections and infestations     
Bronchitis  1  41/348 (11.78%)  37/352 (10.51%) 
Chlamydial infection  1  23/348 (6.61%)  13/352 (3.69%) 
Folliculitis  1  17/348 (4.89%)  18/352 (5.11%) 
Gonorrhoea  1  22/348 (6.32%)  9/352 (2.56%) 
Herpes zoster  1  19/348 (5.46%)  9/352 (2.56%) 
Influenza  1  15/348 (4.31%)  19/352 (5.40%) 
Nasopharyngitis  1  38/348 (10.92%)  34/352 (9.66%) 
Pharyngitis  1  16/348 (4.60%)  22/352 (6.25%) 
Sinusitis  1  41/348 (11.78%)  46/352 (13.07%) 
Syphilis  1  34/348 (9.77%)  33/352 (9.38%) 
Upper respiratory tract infection  1  92/348 (26.44%)  78/352 (22.16%) 
Metabolism and nutrition disorders     
Decreased appetite  1  18/348 (5.17%)  15/352 (4.26%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  33/348 (9.48%)  22/352 (6.25%) 
Back pain  1  38/348 (10.92%)  26/352 (7.39%) 
Pain in extremity  1  21/348 (6.03%)  24/352 (6.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anorectal human papilloma virus infection  1  20/348 (5.75%)  13/352 (3.69%) 
Nervous system disorders     
Dizziness  1  29/348 (8.33%)  94/352 (26.70%) 
Headache  1  62/348 (17.82%)  45/352 (12.78%) 
Somnolence  1  7/348 (2.01%)  28/352 (7.95%) 
Psychiatric disorders     
Abnormal dreams  1  56/348 (16.09%)  101/352 (28.69%) 
Anxiety  1  30/348 (8.62%)  33/352 (9.38%) 
Depression  1  56/348 (16.09%)  59/352 (16.76%) 
Insomnia  1  47/348 (13.51%)  63/352 (17.90%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  13/348 (3.74%)  21/352 (5.97%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  39/348 (11.21%)  26/352 (7.39%) 
Oropharyngeal pain  1  23/348 (6.61%)  32/352 (9.09%) 
Sinus congestion  1  22/348 (6.32%)  14/352 (3.98%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  16/348 (4.60%)  20/352 (5.68%) 
Rash  1  35/348 (10.06%)  53/352 (15.06%) 
Vascular disorders     
Hypertension  1  21/348 (6.03%)  22/352 (6.25%) 
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: NCT01095796     History of Changes
Other Study ID Numbers: GS-US-236-0102
First Submitted: March 17, 2010
First Posted: March 30, 2010
Results First Submitted: September 20, 2012
Results First Posted: October 22, 2012
Last Update Posted: November 11, 2015