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NCT00869557 · ClinicalTrials.gov registry record · Phase 2
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 study of HIV Infections and HIV, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 20
- Study locations
NCT00869557: Completed Phase 2 study of HIV Infections and HIV, sponsored by Gilead Sciences.
NCT00869557 is a Phase 2 study of HIV Infections and HIV that has completed, run by Gilead Sciences. The registered enrollment target is 71 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00869557, a Phase 2 study of HIV Infections and HIV, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
Conditions Studied
Interventions
- DRUG Stribild
- DRUG Atripla
Study Locations (20)
Florida
- Broward Health - Fort Lauderdale
- Gary Richmond, MD, PA, Inc. - Fort Lauderdale
- Wohlfeiler, Piperato and Associates, LLC - Miami Beach
- Orlando Immunology Center - Orlando
- Infectious Disease of Central Florida - Orlando
- Treasure Coast Infectious Disease Consultants - Vero Beach
California
- The Living Hope Foundation - Long Beach
- Peter J. Ruane, MD, Inc. - Los Angeles
- Orange Coast Medical Group - Newport Beach
- East Bay AIDS Center - Oakland
- Metropolis Medical - San Francisco
District of Columbia
- Dupont Circle Physicians Group - Washington D.C.
- Whitman Walker Clinic - Washington D.C.
- Capital Medical Associates PC - Washington D.C.
Arkansas
- Health for Life Clinic, PLLC - Little Rock
Colorado
- Apex Research Institute - Denver
Georgia
- Infectious Disease Specialists of Atlanta (IDSA) - Decatur
Illinois
- Northstar Medical Center - Chicago
Maryland
- Chase Brexton Health Services, Inc. - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT00869557 record still lists
NCT00869557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Stribild is the first listed.
NCT00869557 names 20 study sites across 9 states, led by Florida, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00869557 about?
NCT00869557 is a clinical study titled "Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults". 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) ver...
What is the current status of trial NCT00869557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2009-04. Estimated completion is 2013-09.
What conditions does trial NCT00869557 study?
This clinical trial studies the following conditions: HIV Infections, HIV.
What interventions are being tested in trial NCT00869557?
The interventions under investigation include: Stribild (DRUG), Atripla (DRUG).
Who is sponsoring clinical trial NCT00869557?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00869557 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00869557's enrollment target sits among peer trials
71 311th of 542 higher than 231 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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