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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

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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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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