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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 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: Atripla

  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 97 sites in the United States and 5 sites in Puerto Rico. The first participant was screened on 16 March 2010. The last participant observation for the Week 144 analysis was on 26 June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
917 participants were screened and 707 were randomized. 700 randomized participants received at least one 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) 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

Participant Flow:   Overall Study
    Stribild     Atripla  
STARTED     348     352  
COMPLETED     0     0  
NOT COMPLETED     348     352  
Adverse Event                 10                 19  
Death                 3                 1  
Pregnancy                 1                 0  
Lack of Efficacy                 5                 2  
Investigator's Discretion                 2                 0  
Withdrew Consent                 9                 14  
Lost to Follow-up                 18                 26  
Subject Noncompliance                 4                 9  
Protocol Violation                 1                 0  
Subject Still on Study Treatment                 278                 263  
Subject Joined Other Study                 17                 18  



  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
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
  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
  Hide Serious Adverse Events

Time Frame Adverse events are reported for the double-blind treatment of Stribild or Atripla 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) 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

Serious Adverse Events
    Stribild     Atripla  
Total, serious adverse events      
# participants affected / at risk     66/348 (18.97%)     44/352 (12.50%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Antiphospholipid syndrome † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Thrombocytopenia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Cardiac disorders      
Acute myocardial infarction † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Bradycardia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Intracardiac mass † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Palpitations † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Supraventricular tachycardia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Proctalgia † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Vomiting † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Colitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Diarrhoea † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Gastritis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Haematemesis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Inguinal hernia † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Intestinal mass † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Intestinal perforation † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pancreatitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pancreatitis acute † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Umbilical hernia † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Upper gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     1/348 (0.29%)     2/352 (0.57%)  
Fatigue † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Asthenia † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Chest pain † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Non-cardiac chest pain † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Systemic inflammatory response syndrome † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Cholelithiasis † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Hepatitis alcoholic † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Liver injury † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Immune reconstitution inflammatory syndrome associated kaposi’s sarcoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     8/348 (2.30%)     2/352 (0.57%)  
Appendicitis † 1    
# participants affected / at risk     4/348 (1.15%)     1/352 (0.28%)  
Cellulitis † 1    
# participants affected / at risk     5/348 (1.44%)     0/352 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     1/348 (0.29%)     3/352 (0.85%)  
Gastroenteritis † 1    
# participants affected / at risk     2/348 (0.57%)     1/352 (0.28%)  
Diverticulitis † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Neurosyphilis † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Viral infection † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Abscess limb † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Acute sinusitis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Bronchitis bacterial † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Cellulitis staphylococcal † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Diarrhoea infectious † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Giardiasis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
H1n1 influenza † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Kaposi’s sarcoma † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Meningitis viral † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Muscle abscess † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Ovarian abscess † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pelvic inflammatory disease † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pneumonia legionella † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pulmonary tuberculosis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Pyelonephritis acute † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Rectal abscess † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Secondary syphilis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Sepsis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Skin bacterial infection † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Subcutaneous abscess † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Urinary tract infection † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Injury, poisoning and procedural complications      
Cervical vertebral fracture † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Facial bones fracture † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Femur fracture † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Gun shot wound † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Humerus fracture † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Intentional overdose † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Lumbar vertebral fracture † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Subdural haematoma † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Investigations      
Alanine aminotransferase increased † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Transaminases increased † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Diabetic ketoacidosis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Musculoskeletal and connective tissue disorders      
Arthritis † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Back pain † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Synovitis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Uterine leiomyoma † 1    
# participants affected / at risk     2/348 (0.57%)     1/352 (0.28%)  
Adenocarcinoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Anal cancer † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Anal cancer recurrent † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Anogenital warts † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Bladder cancer recurrent † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Burkitt’s lymphoma † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Diffuse large b-cell lymphoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Hodgkin’s disease † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Lymphoma † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Malignant melanoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Metastatic neoplasm † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Nervous system disorders      
Syncope † 1    
# participants affected / at risk     1/348 (0.29%)     2/352 (0.57%)  
Headache † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Migraine † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Convulsion † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Grand mal convulsion † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Hepatic encephalopathy † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Presyncope † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     2/348 (0.57%)     1/352 (0.28%)  
Suicide attempt † 1    
# participants affected / at risk     1/348 (0.29%)     2/352 (0.57%)  
Bipolar disorder † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Completed suicide † 1    
# participants affected / at risk     1/348 (0.29%)     1/352 (0.28%)  
Alcoholism † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Depression suicidal † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Drug dependence † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Suicidal behaviour † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Suicidal ideation † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Renal and urinary disorders      
Nephrolithiasis † 1    
# participants affected / at risk     0/348 (0.00%)     2/352 (0.57%)  
Renal failure † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Reproductive system and breast disorders      
Pelvic pain † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Testicular mass † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Asthma † 1    
# participants affected / at risk     2/348 (0.57%)     1/352 (0.28%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Dyspnoea † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Dyspnoea exertional † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Pneumomediastinum † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Pulmonary thrombosis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Respiratory failure † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash maculo-papular † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Hypertension † 1    
# participants affected / at risk     2/348 (0.57%)     0/352 (0.00%)  
Haematoma † 1    
# participants affected / at risk     0/348 (0.00%)     1/352 (0.28%)  
Hypertensive crisis † 1    
# participants affected / at risk     1/348 (0.29%)     0/352 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (16.0)




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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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