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Completed Phase 2 Interventional Results available

Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

ClinicalTrials.gov ID: NCT00959894

Public ClinicalTrials.gov record NCT00959894. 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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.

Study identification

NCT ID
NCT00959894
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
80 participants

Conditions and interventions

Conditions

Interventions

Drug

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
Sep 2009 (Type not available)
Primary completion
Feb 2014 (Actual)
Completion
May 2014 (Actual)
Last update posted
Jun 6, 2016

2009 – 2014

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
3
Facility City State ZIP Site status
The University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599-7215 —
Carolinas Medical Center Charlotte North Carolina 28207 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —

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 NCT00959894, 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 6, 2016 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00959894 live on ClinicalTrials.gov.

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