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NCT00959894 · ClinicalTrials.gov registry record · Phase 2
Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection
A Phase 2 study of HIV Infections, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 3
- Study locations
NCT00959894: Completed Phase 2 study of HIV Infections, sponsored by University of North Carolina, Chapel Hill.
NCT00959894 is a Phase 2 study of HIV Infections that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 80 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00959894, a Phase 2 study of HIV Infections, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
The primary study endpoint was the proportion of participants who achieved HIV-1 RNA \<50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA \<50 copies/ml during the Week 24 analysis window (\>18 and \<30 weeks post-entry).
Conditions Studied
Interventions
- DRUG Truvada
- DRUG Etravirine (Intelence)
Study Locations (3)
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
- Carolinas Medical Center - Charlotte
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT00959894 record still lists
NCT00959894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (82% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Truvada is the first listed.
NCT00959894 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00959894 about?
NCT00959894 is a clinical study titled "Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection". 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 pharmacokine...
What is the current status of trial NCT00959894?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2009-09. Estimated completion is 2014-05.
What conditions does trial NCT00959894 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00959894?
The interventions under investigation include: Truvada (DRUG), Etravirine (Intelence) (DRUG).
Who is sponsoring clinical trial NCT00959894?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00959894 being conducted?
This trial has 3 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00959894's enrollment target sits among peer trials
80 299th of 542 higher than 242 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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