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NCT00053638 · ClinicalTrials.gov registry record · Phase 3
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
A Phase 3 study of HIV Infection, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 345
- Enrollment target
- 20
- Study locations
NCT00053638: Completed Phase 3 study of HIV Infection, sponsored by GlaxoSmithKline.
NCT00053638 is a Phase 3 study of HIV Infection that has completed, run by GlaxoSmithKline. The registered enrollment target is 345 participants, above the 238-participant average among 73 other HIV Infection trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00053638, a Phase 3 study of HIV Infection, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 345 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
Conditions Studied
Interventions
- DRUG efavirenz
- DRUG tenofovir
- DRUG abacavir/lamivudine
Study Locations (20)
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Fort Myers
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
- GSK Investigational Site - North Miami
- GSK Investigational Site - Orlando
- GSK Investigational Site - Orlando
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - San Francisco
Colorado
- GSK Investigational Site - Denver
- GSK Investigational Site - Denver
- GSK Investigational Site - Fort Collins
District of Columbia
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
Arizona
- GSK Investigational Site - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-10 |
| Phase | Phase 3 |
What the finished NCT00053638 record still lists
NCT00053638 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, above the 238-participant average among 73 other HIV Infection trials with a reported enrollment target (45% higher).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 3 interventions - of which efavirenz is the first listed.
NCT00053638 names 20 study sites across 5 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00053638 about?
NCT00053638 is a clinical study titled "A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy". This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate...
What is the current status of trial NCT00053638?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2003-02. Estimated completion is 2004-10.
What conditions does trial NCT00053638 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00053638?
The interventions under investigation include: efavirenz (DRUG), tenofovir (DRUG), abacavir/lamivudine (DRUG).
Who is sponsoring clinical trial NCT00053638?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00053638 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00053638's enrollment target sits among peer trials
345 12th of 73 higher than 62 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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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