Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
1 other identifier
interventional
71
1 country
30
Brief Summary
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv
Started Apr 2009
Longer than P75 for phase_2 hiv
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedResults Posted
Study results publicly available
October 22, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 4, 2014
May 1, 2014
7 months
March 24, 2009
September 20, 2012
May 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
Week 24
Secondary Outcomes (5)
The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
Week 48
Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
Baseline to Weeks 24 and 48
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24
Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
Baseline to Week 48
The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL
Baseline to Weeks 24 and 48
Study Arms (2)
Stribild
EXPERIMENTALAtripla
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
- No prior use of any approved or experimental anti-HIV drug
- Normal electrocardiogram (ECG)
- Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
- Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Cluster determinant 4 (CD4) cell count \> 50 cells/µL
- Serum amylase ≤ 1.5 x ULN
- Normal thyroid-stimulating hormone
- Negative serum pregnancy test (for females of childbearing potential only)
- Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
- Life expectancy ≥ 1 year
- Ability to understand and sign a written informed consent form
You may not qualify if:
- New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
- Hepatitis B surface antigen positive
- Hepatitis C antibody positive
- Participants experiencing cirrhosis
- Participants experiencing ascites
- Participants experiencing encephalopathy
- Females who are breastfeeding
- Positive serum pregnancy test (for females of childbearing potential)
- Vaccinated within 90 days of study dosing
- History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
- Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
- Prolonged QTcF interval at screening
- PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
- QRS ≥ 120 msec on ECG at screening
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (30)
Health for Life Clinic, PLLC
Little Rock, Arkansas, 72207, United States
The Living Hope Foundation
Long Beach, California, 90813, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Orange Coast Medical Group
Newport Beach, California, 92663, United States
East Bay AIDS Center
Oakland, California, 94609, United States
Metropolis Medical
San Francisco, California, 94115, United States
Apex Research Institute
Denver, Colorado, 80220, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates PC
Washington D.C., District of Columbia, 20036, United States
Broward Health
Fort Lauderdale, Florida, 33311, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, 33316, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, 33139, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Infectious Disease of Central Florida
Orlando, Florida, 32806, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Infectious Disease Specialists of Atlanta (IDSA)
Decatur, Georgia, 30033, United States
Northstar Medical Center
Chicago, Illinois, 60657, United States
Chase Brexton Health Services, Inc.
Baltimore, Maryland, 21201, United States
Community Research Initiative of New England
Boston, Massachusetts, 02215, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 63139, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505, United States
Chelsea Village Medical
New York, New York, 10011, United States
Ricky K. Hsu, MD, PC
New York, New York, 10011, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Nicholaos Bellos, MD, PA
Dallas, Texas, 75204, United States
AIDS Arms/ Peabody Health Center
Dallas, Texas, 75215, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, 77098, United States
TribalMed
Seattle, Washington, 98103, United States
Related Publications (1)
Cohen C, Elion R, Ruane P, Shamblaw D, DeJesus E, Rashbaum B, Chuck SL, Yale K, Liu HC, Warren DR, Ramanathan S, Kearney BP. Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS. 2011 Mar 27;25(6):F7-12. doi: 10.1097/QAD.0b013e328345766f.
PMID: 21412057RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2009
First Posted
March 26, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2009
Study Completion
September 1, 2013
Last Updated
June 4, 2014
Results First Posted
October 22, 2012
Record last verified: 2014-05