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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01106586
First received: April 14, 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: ATV/r + Truvada

  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 participant observation for the Week 48 analysis was on 13 September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1017 subjects were screened; 715 were randomized (357 to the Stribild group and 358 to the ATV/r + Truvada group) of which 61.4% (439) had screening HIV-1 ribonucleic acid (RNA) ≤ 100,000 copies/mL. A total of 708 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) + placebos to match ATV/r + Truvada once daily (QD)
ATV/r + Truvada Double-blind atazanavir 300 mg/ritonavir 100 mg (ATV/r) + emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (Truvada) + placebo to match Stribild QD

Participant Flow:   Overall Study
    Stribild     ATV/r + Truvada  
STARTED     353     355  
COMPLETED     0     0  
NOT COMPLETED     353     355  
Adverse Event                 13                 18  
Pregnancy                 1                 0  
Lack of Efficacy                 4                 1  
Physician Decision                 1                 3  
Withdrawal by Subject                 1                 6  
Lost to Follow-up                 7                 7  
Participant Noncompliance                 5                 5  
Protocol Violation                 1                 0  
Subjects Still on Study Treatment                 320                 315  



  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 + placebos to match ATV/r + Truvada QD
ATV/r + Truvada Double-blind ATV/r + Truvada + placebo to match Stribild QD
Total Total of all reporting groups

Baseline Measures
    Stribild     ATV/r + Truvada     Total  
Number of Participants  
[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     203     214     417  
> 100,000     150     141     291  
CD4 Cell Count (/µL)  
[units: participants]
     
≤ 50     12     5     17  
51 to ≤ 200     42     34     76  
201 to ≤ 350     122     124     246  
351 to ≤ 500     122     122     244  
> 500     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   [ 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 period of Stribild or ATV/r + Truvada up to the Week 48 database cut
Additional Description No text entered.

Reporting Groups
  Description
Stribild Double-blind Stribild + placebos to match ATV/r + Truvada QD
ATV/r + Truvada Double-blind ATV/r + Truvada + placebo to match Stribild QD

Serious Adverse Events
    Stribild     ATV/r + Truvada  
Total, serious adverse events      
# participants affected / at risk     26/353 (7.37%)     31/355 (8.73%)  
Congenital, familial and genetic disorders      
Congenital ureteric anomaly † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     0/353 (0.00%)     2/355 (0.56%)  
Diverticulum † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Erosive oesophagitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Pancreatitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Peritonitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Hepatobiliary disorders      
Bile duct stone † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Infections and infestations      
Appendicitis † 1    
# participants affected / at risk     2/353 (0.57%)     1/355 (0.28%)  
Cellulitis † 1    
# participants affected / at risk     1/353 (0.28%)     2/355 (0.56%)  
Anal abscess † 1    
# participants affected / at risk     1/353 (0.28%)     2/355 (0.56%)  
Osteomyelitis † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Breast abscess † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Ear infection † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Gastroenteritis viral † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Impetigo † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Malignant syphilis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Meningitis viral † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pilonidal cyst † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pneumonia † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pneumonia bacterial † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Pyelonephritis acute † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Septic shock † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Shigella infection † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Staphylococcal infection † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Tonsillitis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Urinary tract infection † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Viral infection † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Injury, poisoning and procedural complications      
Femur fracture † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Muscle strain † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Overdose † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Toxicity to various agents † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Upper limb fracture † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Investigations      
Blood creatine phosphokinase increased † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Musculoskeletal and connective tissue disorders      
Rhabdomyolysis † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Anal cancer † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
B-cell lymphoma Stage II † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Bladder neoplasm † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Burkitt's lymphoma † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Hodgkin's disease † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Nervous system disorders      
Cervicobrachial syndrome † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Convulsion † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Syncope † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Psychiatric disorders      
Schizophrenia † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Alcohol withdrawal syndrome † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Bipolar disorder † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Depressed mood † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Depression † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Major depression † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Substance abuse † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Suicide attempt † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Renal and urinary disorders      
Hydronephrosis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Nephrolithiasis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Reproductive system and breast disorders      
Epididymitis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Respiratory, thoracic and mediastinal disorders      
Pneumonia aspiration † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Respiratory depression † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Respiratory distress † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Tonsillar hypertrophy † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Skin and subcutaneous tissue disorders      
Drug eruption † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Vascular disorders      
Ischaemia † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Thrombophlebitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Venous thrombosis limb † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (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
No text entered.


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