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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

HIV Infection

Treatments

Drug: abacavir/lamivudine

Drug: tenofovir

Drug: efavirenz

Study type

Interventional

Funder types

Industry

Identifiers

NCT00053638

ESS30009

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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