Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Public ClinicalTrials.gov record NCT00892437. 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 GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) 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 study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. 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, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.
Study identification
- NCT ID
- NCT00892437
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 85 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
- May 2009 (Type not available)
- Primary completion
- Dec 2009 (Actual)
- Completion
- Jan 2015 (Actual)
- Last update posted
- Feb 15, 2016
2009 – 2015
United States locations
- U.S. sites
- 31
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Center for HIV/AIDS | Phoenix | Arizona | 85006 | — |
| Health for Life Clinic, PLLC | Little Rock | Arkansas | 72207 | — |
| AIDS Healthcare Foundation-Research Center | Beverly Hills | California | 90804 | — |
| 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 | — |
| David J. Shamblaw, MD Inc. | San Diego | California | 92103 | — |
| Metropolis Medical | San Francisco | California | 94115 | — |
| Denver Infectious Disease Consultants, PLLC | 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 | — |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | 33316 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| ValuehealthMD, LLC | Orlando | Florida | 32806 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Infectious Disease Specialists of Atlanta (IDSA) | Decatur | Georgia | 30033 | — |
| Northstar Medical Center | Chicago | Illinois | 60657 | — |
| Chase Brexton Health Services, Inc. | Baltimore | Maryland | 21201 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Central West Healthcare | St Louis | Missouri | 63108 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | — |
| 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 | — |
| Therapeutic Concepts, P.A. | Houston | Texas | 77478 | — |
| 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 NCT00892437, 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 Feb 15, 2016 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00892437 live on ClinicalTrials.gov.