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A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy | Clinical Trials | Clareo Health

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A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

NCT00053638•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must be able to provide informed consent.
•Have documented HIV-1 infection.
•Have not received more than 14 days of prior treatment with antiretroviral drugs.
•Meet laboratory test criteria.
•Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
•Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion Criteria

•Enrolled in other HIV treatment studies.
•Pregnant or breastfeeding.

Locations (58)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Fort Collins, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

Key Dates

Start Date

February 1, 2003

Primary Completion Date

October 1, 2004

Completion Date

October 1, 2004

Last Updated

October 4, 2010

Enrollment

345

Estimated participants

Conditions

HIV Infection

Interventions

efavirenz

DRUG

tenofovir

DRUG

abacavir/lamivudine

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITING

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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