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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 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.

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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

HIV Infection

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

FieldValue
Enrollment Target 345 participants
Start Date 2003-02
Est. Completion 2004-10
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00053638

The ClinicalTrials.gov registry entry for NCT00053638 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 238-participant average among 73 other HIV Infection trials with a reported enrollment target (45% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.