Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Public ClinicalTrials.gov record NCT00869557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00869557
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2009 (Type not available)
- Primary completion
- Nov 2009 (Actual)
- Completion
- Sep 2013 (Actual)
- Last update posted
- Jun 4, 2014
2009 – 2013
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Health for Life Clinic, PLLC | Little Rock | Arkansas | 72207 | — |
| The Living Hope Foundation | Long Beach | California | 90813 | — |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | — |
| Orange Coast Medical Group | Newport Beach | California | 92663 | — |
| East Bay AIDS Center | Oakland | California | 94609 | — |
| Metropolis Medical | San Francisco | California | 94115 | — |
| Apex Research Institute | Denver | Colorado | 80220 | — |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | — |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| Capital Medical Associates PC | Washington D.C. | District of Columbia | 20036 | — |
| Broward Health | Fort Lauderdale | Florida | 33311 | — |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | 33316 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Infectious Disease of Central Florida | Orlando | Florida | 32806 | — |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | — |
| Infectious Disease Specialists of Atlanta (IDSA) | Decatur | Georgia | 30033 | — |
| Northstar Medical Center | Chicago | Illinois | 60657 | — |
| Chase Brexton Health Services, Inc. | Baltimore | Maryland | 21201 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | — |
| Chelsea Village Medical | New York | New York | 10011 | — |
| Ricky K. Hsu, MD, PC | New York | New York | 10011 | — |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | — |
| Nicholaos Bellos, MD, PA | Dallas | Texas | 75204 | — |
| AIDS Arms/ Peabody Health Center | Dallas | Texas | 75215 | — |
| Gordon E. Crofoot, MD, PA | Houston | Texas | 77098 | — |
| TribalMed | Seattle | Washington | 98103 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00869557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2014 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00869557 live on ClinicalTrials.gov.