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NCT00734344 · ClinicalTrials.gov registry record · NA
Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT00734344: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT00734344 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00734344, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than a commitment to life-long HAART, as has been the experimental approach in a variety of clinical protocols in the United States and Europe. Subjects will complete a 12 week course of therapy, and those who meet treatment-response and safety criteria will then undergo a similarly intensive period of virology and immunology monitoring to compare the timing and dynamics of any observed virologic rebound following the treatment intervention.
Primary Outcome
Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Interventions
- DRUG Efavirenz
- DRUG Raltegravir
- DRUG Emtricitibine
- DRUG Tenofovir disoproxil once daily
- DRUG Tenofovir disoproxil twice daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-09 |
| Phase | NA |
What the finished NCT00734344 record still lists
NCT00734344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Efavirenz is the first listed.
NCT00734344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00734344 about?
NCT00734344 is a clinical study titled "Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection". This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravi...
What is the current status of trial NCT00734344?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2008-09. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00734344?
The interventions under investigation include: Efavirenz (DRUG), Raltegravir (DRUG), Emtricitibine (DRUG), Tenofovir disoproxil once daily (DRUG), Tenofovir disoproxil twice daily (DRUG).
Who is sponsoring clinical trial NCT00734344?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00734344's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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