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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01095796
First received: March 17, 2010
Last updated: October 15, 2015
Last verified: October 2015
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
Drug: Stribild Placebo
Drug: Atripla Placebo

  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 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
917 participants were screened.

Reporting Groups
  Description
Stribild 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 Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily

Participant Flow:   Overall Study
    Stribild     Atripla  
STARTED     353     354  
COMPLETED     58     65  
NOT COMPLETED     295     289  
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  



  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.
Safety Analysis Set: participants were randomized and received at least one dose of study medication.

Reporting Groups
  Description
Stribild 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 Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
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 at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   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   [ Time Frame: Week 96 ]

3.  Secondary:   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   [ Time Frame: Week 144 ]

4.  Secondary:   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   [ Time Frame: Week 192 ]

5.  Secondary:   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   [ Time Frame: Week 48 ]

6.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192   [ Time Frame: Baseline; Weeks 48, 96, 144, and 192 ]

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame Up to 218 weeks plus 30 days
Additional Description Safety Analysis Set: participants were randomized and received at least one dose of study drug.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Stribild 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 Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily

Other Adverse Events
    Stribild     Atripla  
Total, other (not including serious) adverse events      
# participants affected / at risk     313/348 (89.94%)     326/352 (92.61%)  
Blood and lymphatic system disorders      
Lymphadenopathy † 1    
# participants affected / at risk     16/348 (4.60%)     18/352 (5.11%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     24/348 (6.90%)     18/352 (5.11%)  
Constipation † 1    
# participants affected / at risk     22/348 (6.32%)     14/352 (3.98%)  
Diarrhoea † 1    
# participants affected / at risk     93/348 (26.72%)     91/352 (25.85%)  
Dyspepsia † 1    
# participants affected / at risk     19/348 (5.46%)     10/352 (2.84%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     19/348 (5.46%)     14/352 (3.98%)  
Haemorrhoids † 1    
# participants affected / at risk     23/348 (6.61%)     13/352 (3.69%)  
Nausea † 1    
# participants affected / at risk     80/348 (22.99%)     59/352 (16.76%)  
Vomiting † 1    
# participants affected / at risk     28/348 (8.05%)     23/352 (6.53%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     53/348 (15.23%)     61/352 (17.33%)  
Pyrexia † 1    
# participants affected / at risk     21/348 (6.03%)     23/352 (6.53%)  
Infections and infestations      
Bronchitis † 1    
# participants affected / at risk     41/348 (11.78%)     37/352 (10.51%)  
Chlamydial infection † 1    
# participants affected / at risk     23/348 (6.61%)     13/352 (3.69%)  
Folliculitis † 1    
# participants affected / at risk     17/348 (4.89%)     18/352 (5.11%)  
Gonorrhoea † 1    
# participants affected / at risk     22/348 (6.32%)     9/352 (2.56%)  
Herpes zoster † 1    
# participants affected / at risk     19/348 (5.46%)     9/352 (2.56%)  
Influenza † 1    
# participants affected / at risk     15/348 (4.31%)     19/352 (5.40%)  
Nasopharyngitis † 1    
# participants affected / at risk     38/348 (10.92%)     34/352 (9.66%)  
Pharyngitis † 1    
# participants affected / at risk     16/348 (4.60%)     22/352 (6.25%)  
Sinusitis † 1    
# participants affected / at risk     41/348 (11.78%)     46/352 (13.07%)  
Syphilis † 1    
# participants affected / at risk     34/348 (9.77%)     33/352 (9.38%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     92/348 (26.44%)     78/352 (22.16%)  
Metabolism and nutrition disorders      
Decreased appetite † 1    
# participants affected / at risk     18/348 (5.17%)     15/352 (4.26%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     33/348 (9.48%)     22/352 (6.25%)  
Back pain † 1    
# participants affected / at risk     38/348 (10.92%)     26/352 (7.39%)  
Pain in extremity † 1    
# participants affected / at risk     21/348 (6.03%)     24/352 (6.82%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Anorectal human papilloma virus infection † 1    
# participants affected / at risk     20/348 (5.75%)     13/352 (3.69%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     29/348 (8.33%)     94/352 (26.70%)  
Headache † 1    
# participants affected / at risk     62/348 (17.82%)     45/352 (12.78%)  
Somnolence † 1    
# participants affected / at risk     7/348 (2.01%)     28/352 (7.95%)  
Psychiatric disorders      
Abnormal dreams † 1    
# participants affected / at risk     56/348 (16.09%)     101/352 (28.69%)  
Anxiety † 1    
# participants affected / at risk     30/348 (8.62%)     33/352 (9.38%)  
Depression † 1    
# participants affected / at risk     56/348 (16.09%)     59/352 (16.76%)  
Insomnia † 1    
# participants affected / at risk     47/348 (13.51%)     63/352 (17.90%)  
Reproductive system and breast disorders      
Erectile dysfunction † 1    
# participants affected / at risk     13/348 (3.74%)     21/352 (5.97%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     39/348 (11.21%)     26/352 (7.39%)  
Oropharyngeal pain † 1    
# participants affected / at risk     23/348 (6.61%)     32/352 (9.09%)  
Sinus congestion † 1    
# participants affected / at risk     22/348 (6.32%)     14/352 (3.98%)  
Skin and subcutaneous tissue disorders      
Dermatitis † 1    
# participants affected / at risk     16/348 (4.60%)     20/352 (5.68%)  
Rash † 1    
# participants affected / at risk     35/348 (10.06%)     53/352 (15.06%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     21/348 (6.03%)     22/352 (6.25%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 17.0



  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
There were no limitations affecting the analysis or results.


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