Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women
Public ClinicalTrials.gov record NCT00984152. 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
Open Label, Randomized Trial of TDF/FTC+Raltegravir Vs. TDF/FTC+Efavirenz in HIV-1-Infected Women: Differential Effects on Viral Suppression/Reservoir, & Immune Parameters in Different Compartments, Including Gut & Genital Tract
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Raltegravir not only has a unique mechanism of action, but may also have other unique effects on suppression of viral replication, viral reservoir, and immune reconstitution in blood and other important compartments. This may in part be due to the pharmacokinetics of Raltegravir in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug in this study, with both drugs being used as part of a three-drug regimen with tenofovir and emtricitabine. The primary objectives are to determine differences in the effects of 2 anti-retroviral regimens, Raltegravir + Truvada versus Atripla, with respect to: 1. Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ hybridization). 2. Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract. 3. Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles. The secondary objective is to determine the pharmacokinetics of Raltegravir in blood and gut tissue; relative tissue/compartment penetration compared to Efavirenz.
Study identification
- NCT ID
- NCT00984152
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- TDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily Drug
- TDF/FTC + Efavirenz (Atripla) Once-Daily Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- Female
- 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 31, 2011
- Primary completion
- May 31, 2013
- Completion
- Nov 30, 2013
- Last update posted
- May 5, 2015
2011 – 2013
United States locations
- U.S. sites
- 5
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mt. Sinai Hospital | Chicago | Illinois | 60608 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| The Ruth M. Rothstein CORE Center (of Cook County) | Chicago | Illinois | 60622 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
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 NCT00984152, 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 May 5, 2015 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00984152 live on ClinicalTrials.gov.