Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
Public ClinicalTrials.gov record NCT01533259. 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 3B Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) Single-Tablet Regimen (STR) in Virologically Suppressed, HIV-1 Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA \< 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.
Study identification
- NCT ID
- NCT01533259
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 48 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
- Dec 31, 2011
- Primary completion
- Oct 31, 2012
- Completion
- Jun 30, 2013
- Last update posted
- Jan 25, 2015
2012 – 2013
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente Los Angeles | Los Angeles | California | 90027 | — |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | — |
| Anthony Mills MD, Inc | Los Angeles | California | 90069 | — |
| Dupont Circle Physician's Group | Washington D.C. | District of Columbia | 20009 | — |
| Capital Medical Associates, PC | Washington D.C. | District of Columbia | 20036 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| Gordon E. Crofoot, MD, PA | Houston | Texas | 77098 | — |
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 NCT01533259, 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 Jan 25, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01533259 live on ClinicalTrials.gov.