Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01095796
First received: March 17, 2010
Last updated: April 16, 2014
Last verified: April 2014
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: Stribild
Drug: Atripla

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 97 sites in the United States and 5 sites in Puerto Rico. The first participant was screened on 16 March 2010. The last participant observation for the Week 48 analysis was on 10 August 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
917 participants were screened; 707 were randomized (353 to the Stribild group and 354 to the Atripla group) of which 66.5% (470) had screening HIV-1 ribonucleic acid (RNA) ≤ 100,000 copies/mL. A total of 700 randomized participants received at least 1 dose of study medication and comprised the safety and intent-to treat (ITT) analysis sets.

Reporting Groups
  Description
Stribild Double-blind Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS)
Atripla Double-blind Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD

Participant Flow:   Overall Study
    Stribild     Atripla  
STARTED     348     352  
COMPLETED     0     0  
NOT COMPLETED     348     352  
Adverse Event                 12                 18  
Death                 1                 1  
Pregnancy                 1                 0  
Lack of Efficacy                 5                 4  
Physician Decision                 1                 0  
Withdrawal by Subject                 3                 5  
Lost to Follow-up                 10                 12  
Participant Noncompliance                 3                 6  
Protocol Violation                 1                 0  
Subjects Still on Study Treatment                 311                 306  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stribild Double-blind Stribild QD and placebo to match Atripla QHS
Atripla Double-blind Atripla QHS and placebo matching Stribild QD
Total Total of all reporting groups

Baseline Measures
    Stribild     Atripla     Total  
Number of Participants  
[units: participants]
  348     352     700  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 10.4     38  ± 10.6     38  ± 10.5  
Gender  
[units: participants]
     
Female     41     36     77  
Male     307     316     623  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
     
United States     348     352     700  
HIV Disease Status  
[units: participants]
     
Asymptomatic     290     295     585  
Symptomatic HIV Infections     30     33     63  
AIDS     28     24     52  
Hepatitis B Virus (HBV) Infection Status  
[units: participants]
     
Negative     343     343     686  
Positive     5     9     14  
Hepatitis C Virus (HCV) Infection Status  
[units: participants]
     
Negative     331     337     668  
Positive     17     15     32  
HIV-1 RNA Category (copies/mL)  
[units: participants]
     
≤ 100,000     230     236     466  
> 100,000     118     116     234  
CD4 Cell Count (/µL)  
[units: 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  



  Outcome Measures
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1.  Primary:   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   [ Time Frame: Week 48 ]

2.  Secondary:   The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Week 48 ]

3.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   The Percentage of Participants With HIV-1 RNA < 50 Copies/mL   [ Time Frame: Week 48 ]


  Serious Adverse Events
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Time Frame Adverse events are reported for the double-blind treatment of Stribild or Atripla up to the Week 48 database cut
Additional Description No text entered.

Reporting Groups
  Description
Stribild Double-blind Stribild QD and placebo to match Atripla QHS
Atripla Double-blind Atripla QHS and placebo to match Stribild QD

Serious Adverse Events
    Stribild     Atripla  
Total, serious adverse events      
# participants affected / at risk     41/348 (11.78%)     24/352 (6.82%)  
Blood and lymphatic system disorders      
Thrombocytopenia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Cardiac disorders      
Acute myocardial infarction † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Intracardiac mass † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Colitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Gastritis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pancreatitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Proctalgia † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Vomiting † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     0/348 (0.00%)     2/352 (0.57%)  
Asthenia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Cholelithiasis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Hepatitis alcoholic † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Liver injury † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Antiphospholipid syndrome † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Immune reconstitution syndrome † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     4/348 (1.15%)     1/352 (0.28%)  
Appendicitis † 1    
# participants affected / at risk     3/348 (0.86%)     1/352 (0.28%)  
Cellulitis † 1    
# participants affected / at risk     4/348 (1.15%)     0/352 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Anogenital warts † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Bronchitis bacterial † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Diarrhoea infectious † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Diverticulitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Meningitis viral † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Muscle abscess † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Neurosyphilis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Pulmonary tuberculosis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Urinary tract infection † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Viral infection † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Injury, poisoning and procedural complications      
Alcohol poisoning † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Lumbar vertebral fracture † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Investigations      
Alanine aminotransferase increased † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Transaminase increased † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Diabetic ketoacidosis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Musculoskeletal and connective tissue disorders      
Synovitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Uterine leiomyoma † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Adenocarcinoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Anal cancer † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Bladder cancer recurrent † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Disseminated large cell lymphoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Kaposi's sarcoma † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Lymphoma † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Malignant melanoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Metastatic neoplasm † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     2/348 (0.57%)     1/352 (0.28%)  
Syncope † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Convulsion † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Grand mal convulsion † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Presyncope † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Psychiatric disorders      
Completed suicide † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Depression † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Suicide attempt † 1    
# participants affected / at risk     0/348 (0.00%)     2/352 (0.57%)  
Alcoholism † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Bipolar disorder † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Renal and urinary disorders      
Renal failure † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Reproductive system and breast disorders      
Pelvic pain † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Respiratory, thoracic and mediastinal disorders      
Asthma † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Dyspnoea † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Dyspnoea exertional † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Respiratory failure † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash maculo-papular † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Hypertension † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Hypertensive crisis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (14.0)




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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