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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 23, 2014
Last verified: October 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 + FTC/TDF

  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 144 analysis was on 09 August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1017 subjects were screened and 715 were randomized. 708 randomized participants received at least 1 dose of study medication and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.

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     0     0  
NOT COMPLETED     353     355  
Adverse Event                 8                 14  
Death                 1                 3  
Pregnancy                 1                 1  
Lack of Efficacy                 1                 0  
Investigator's Discretion                 3                 5  
Withdrew Consent                 12                 18  
Lost to Follow-up                 20                 16  
Subject Noncompliance                 12                 9  
Protocol Violation                 1                 0  
Subject Still on Study Treatment                 255                 259  
Subject Joined Other Study                 39                 30  



  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 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  
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
  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 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 ]

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

6.  Secondary:   The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ 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 144 data cut.
Additional Description 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) 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

Serious Adverse Events
    Stribild     ATV/r + FTC/TDF  
Total, serious adverse events      
# participants affected / at risk     51/353 (14.45%)     59/355 (16.62%)  
Cardiac disorders      
Myocardial infarction † 1    
# participants affected / at risk     1/353 (0.28%)     2/355 (0.56%)  
Angina pectoris † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Congenital, familial and genetic disorders      
Congenital ureteric anomaly † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Eye disorders      
Iridocyclitis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     1/353 (0.28%)     4/355 (1.13%)  
Colitis † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Constipation † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Diarrhoea † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
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%)  
Gastritis erosive † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Haemorrhoids † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Intestinal obstruction † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Large intestine perforation † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Lower gastrointestinal haemorrhage † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pancreatitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Peptic ulcer haemorrhage † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Vomiting † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
General disorders      
Asthenia † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Chest pain † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pyrexia † 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%)  
Cholecystitis † 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      
Anal abscess † 1    
# participants affected / at risk     1/353 (0.28%)     3/355 (0.85%)  
Appendicitis † 1    
# participants affected / at risk     3/353 (0.85%)     1/355 (0.28%)  
Cellulitis † 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%)  
Peritonitis † 1    
# participants affected / at risk     2/353 (0.57%)     0/355 (0.00%)  
Pneumonia † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Septic shock † 1    
# participants affected / at risk     0/353 (0.00%)     2/355 (0.56%)  
Abscess limb † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Abscess neck † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Appendicitis perforated † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Arthritis infective † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
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%)  
Device related infection † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Ear infection † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Enterocolitis infectious † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Gastroenteritis cryptosporidial † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Gastrointestinal infection † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Herpes zoster oticus † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Impetigo † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Incision site infection † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Malaria † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Malignant syphilis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Meningitis aseptic † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Meningitis enteroviral † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Meningitis viral † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Orchitis † 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 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%)  
Respiratory syncytial virus infection † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Salpingitis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Secondary syphilis † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
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      
Overdose † 1    
# participants affected / at risk     2/353 (0.57%)     1/355 (0.28%)  
Toxicity to various agents † 1    
# participants affected / at risk     1/353 (0.28%)     2/355 (0.56%)  
Upper limb fracture † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Ankle fracture † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Clavicle fracture † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Femur fracture † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Hand fracture † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Lower limb fracture † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Lumbar vertebral fracture † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Muscle rupture † 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%)  
Post concussion syndrome † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Skull fractured base † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Wrist 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%)  
Hyperkalaemia † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Musculoskeletal and connective tissue disorders      
Rhabdomyolysis † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Arthralgia † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Arthritis reactive † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Foot deformity † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Neck pain † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Pain in jaw † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Hodgkin’s disease † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
Anal cancer † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Anal neoplasm † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Anogenital warts † 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%)  
Basal cell carcinoma † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Bladder cancer † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
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%)  
Nervous system disorders      
Convulsion † 1    
# participants affected / at risk     2/353 (0.57%)     0/355 (0.00%)  
Cervicobrachial syndrome † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Coma † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Critical illness polyneuropathy † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Haemorrhage intracranial † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Headache † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Hypoaesthesia † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Syncope † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Tension headache † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Transient ischaemic attack † 1    
# participants affected / at risk     1/353 (0.28%)     0/355 (0.00%)  
Viith nerve paralysis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Psychiatric disorders      
Suicide attempt † 1    
# participants affected / at risk     2/353 (0.57%)     2/355 (0.56%)  
Depression † 1    
# participants affected / at risk     2/353 (0.57%)     1/355 (0.28%)  
Schizophrenia † 1    
# participants affected / at risk     1/353 (0.28%)     2/355 (0.56%)  
Suicidal ideation † 1    
# participants affected / at risk     2/353 (0.57%)     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%)  
Depressive symptom † 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%)  
Mania † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Post-traumatic stress disorder † 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%)  
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%)  
Renal colic † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Reproductive system and breast disorders      
Epididymitis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Respiratory, thoracic and mediastinal disorders      
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/353 (0.28%)     1/355 (0.28%)  
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%)  
Psoriasis † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
Vascular disorders      
Orthostatic hypotension † 1    
# participants affected / at risk     0/353 (0.00%)     1/355 (0.28%)  
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 (16.0)




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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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