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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 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734344
The ClinicalTrials.gov registry entry for NCT00734344 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Efavirenz is the first listed.
NCT00734344 reports 0 study locations.
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.
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