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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01106586
First received: April 14, 2010
Last updated: October 9, 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: ATV
Drug: Ritonavir
Drug: FTC/TDF
Drug: Stribild Placebo
Drug: ATV Placebo
Drug: RTV Placebo
Drug: FTC/TDF 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 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1017 subjects 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) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
ATV/r + FTC/TDF ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily

Participant Flow:   Overall Study
    Stribild   ATV/r + FTC/TDF
STARTED   353   355 
COMPLETED   68   70 
NOT COMPLETED   285   285 
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 



  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 who were randomized into the study and received at least 1 dose of study drug

Reporting Groups
  Description
Stribild 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 + FTC/TDF ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Total Total of all reporting groups

Baseline Measures
   Stribild   ATV/r + FTC/TDF   Total 
Overall Participants Analyzed 
[Units: Participants]
 353   355   708 
Age 
[Units: Years]
Mean (Standard Deviation)
 38  (10.5)   39  (9.8)   38  (10.2) 
Gender 
[Units: Participants]
     
Female   29   39   68 
Male   324   316   640 
Race/Ethnicity, Customized 
[Units: 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 
[Units: 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 
[Units: Participants]
     
Asymptomatic   285   293   578 
Symptomatic HIV Infections   36   38   74 
AIDS   32   24   56 
Hepatitis B Virus (HBV) Infection Status 
[Units: Participants]
     
Negative   347   346   693 
Positive   5   7   12 
Indeterminate   0   1   1 
Not done   1   1   2 
Hepatitis C Virus (HCV) Infection Status 
[Units: Participants]
     
Negative   335   344   679 
Positive   18   10   28 
Indeterminate   0   0   0 
Not done   0   1   1 
HIV-1 RNA Category (copies/mL) 
[Units: Participants]
     
≤ 100,000 copies/mL   203   214   417 
> 100,000 copies/mL   150   141   291 
CD4 Cell Count (/µL) 
[Units: 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 


  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 Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Additional Description Safety Analysis Set: participants who were randomized into the study and received at least 1 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) plus placebo to match ATV/r + FTC/TDF once daily
ATV/r + FTC/TDF ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily

Other Adverse Events
    Stribild   ATV/r + FTC/TDF
Total, other (not including serious) adverse events     
# participants affected / at risk   326/353 (92.35%)   326/355 (91.83%) 
Blood and lymphatic system disorders     
Lymphadenopathy † 1     
# participants affected / at risk   23/353 (6.52%)   16/355 (4.51%) 
Eye disorders     
Ocular icterus † 1     
# participants affected / at risk   2/353 (0.57%)   52/355 (14.65%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   25/353 (7.08%)   26/355 (7.32%) 
Constipation † 1     
# participants affected / at risk   20/353 (5.67%)   14/355 (3.94%) 
Diarrhoea † 1     
# participants affected / at risk   99/353 (28.05%)   121/355 (34.08%) 
Dyspepsia † 1     
# participants affected / at risk   13/353 (3.68%)   19/355 (5.35%) 
Flatulence † 1     
# participants affected / at risk   16/353 (4.53%)   32/355 (9.01%) 
Nausea † 1     
# participants affected / at risk   80/353 (22.66%)   78/355 (21.97%) 
Vomiting † 1     
# participants affected / at risk   26/353 (7.37%)   35/355 (9.86%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   60/353 (17.00%)   60/355 (16.90%) 
Pyrexia † 1     
# participants affected / at risk   23/353 (6.52%)   22/355 (6.20%) 
Hepatobiliary disorders     
Jaundice † 1     
# participants affected / at risk   0/353 (0.00%)   34/355 (9.58%) 
Immune system disorders     
Seasonal allergy † 1     
# participants affected / at risk   17/353 (4.82%)   19/355 (5.35%) 
Infections and infestations     
Bronchitis † 1     
# participants affected / at risk   47/353 (13.31%)   42/355 (11.83%) 
Chlamydial infection † 1     
# participants affected / at risk   18/353 (5.10%)   17/355 (4.79%) 
Folliculitis † 1     
# participants affected / at risk   19/353 (5.38%)   22/355 (6.20%) 
Gastroenteritis † 1     
# participants affected / at risk   18/353 (5.10%)   28/355 (7.89%) 
Herpes zoster † 1     
# participants affected / at risk   15/353 (4.25%)   20/355 (5.63%) 
Influenza † 1     
# participants affected / at risk   31/353 (8.78%)   24/355 (6.76%) 
Nasopharyngitis † 1     
# participants affected / at risk   53/353 (15.01%)   57/355 (16.06%) 
Onychomycosis † 1     
# participants affected / at risk   21/353 (5.95%)   13/355 (3.66%) 
Pharyngitis † 1     
# participants affected / at risk   23/353 (6.52%)   18/355 (5.07%) 
Sinusitis † 1     
# participants affected / at risk   35/353 (9.92%)   38/355 (10.70%) 
Syphilis † 1     
# participants affected / at risk   27/353 (7.65%)   29/355 (8.17%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   86/353 (24.36%)   97/355 (27.32%) 
Urinary tract infection † 1     
# participants affected / at risk   18/353 (5.10%)   20/355 (5.63%) 
Metabolism and nutrition disorders     
Decreased appetite † 1     
# participants affected / at risk   14/353 (3.97%)   19/355 (5.35%) 
Vitamin D deficiency † 1     
# participants affected / at risk   21/353 (5.95%)   19/355 (5.35%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   35/353 (9.92%)   32/355 (9.01%) 
Back pain † 1     
# participants affected / at risk   46/353 (13.03%)   37/355 (10.42%) 
Pain in extremity † 1     
# participants affected / at risk   22/353 (6.23%)   21/355 (5.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anorectal human papilloma virus infection † 1     
# participants affected / at risk   21/353 (5.95%)   12/355 (3.38%) 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   25/353 (7.08%)   28/355 (7.89%) 
Headache † 1     
# participants affected / at risk   67/353 (18.98%)   55/355 (15.49%) 
Paraesthesia † 1     
# participants affected / at risk   9/353 (2.55%)   21/355 (5.92%) 
Psychiatric disorders     
Anxiety † 1     
# participants affected / at risk   22/353 (6.23%)   29/355 (8.17%) 
Depression † 1     
# participants affected / at risk   47/353 (13.31%)   52/355 (14.65%) 
Insomnia † 1     
# participants affected / at risk   37/353 (10.48%)   36/355 (10.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   38/353 (10.76%)   46/355 (12.96%) 
Oropharyngeal pain † 1     
# participants affected / at risk   19/353 (5.38%)   32/355 (9.01%) 
Skin and subcutaneous tissue disorders     
Night sweats † 1     
# participants affected / at risk   10/353 (2.83%)   18/355 (5.07%) 
Rash † 1     
# participants affected / at risk   30/353 (8.50%)   37/355 (10.42%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   24/353 (6.80%)   12/355 (3.38%) 
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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