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NCT00537394 · ClinicalTrials.gov registry record · Phase 3
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
NCT00537394: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00537394 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 517 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00537394, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
Study Summary
The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.
Primary Outcome
Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: \< 1.0 log10 copies/mL reduction from baseline level and \>= 200 copies/mL at or after week 12 evaluation; \>= 200 copies/mL after 1 measurement \< 200 copies/mL; absence of any values \< 200 copies/mL by and including week 24 evaluation; \>= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those rand
Interventions
- DRUG Etravirine
- DRUG Raltegravir
- DRUG Darunavir
- DRUG Enfuvirtide
- DRUG Tipranavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2008-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT00537394 record still lists
NCT00537394 is an interventional study that assigns participants to a tested intervention. The registered 517 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 5 interventions - of which Etravirine is the first listed.
NCT00537394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00537394 about?
NCT00537394 is a clinical study titled "Optimizing Treatment for Treatment-Experienced, HIV-Infected People". The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit o...
What is the current status of trial NCT00537394?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2008-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00537394?
The interventions under investigation include: Etravirine (DRUG), Raltegravir (DRUG), Darunavir (DRUG), Enfuvirtide (DRUG), Tipranavir (DRUG).
Who is sponsoring clinical trial NCT00537394?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00537394's enrollment target sits among peer trials
517 724th of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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