A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Lamivudine; Drug: Amprenavir; Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002195

264D

PROA3001

Details and patient eligibility

About

The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.

Full description

This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• HIV-positive status.
• Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
• CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Clinical diagnosis of AIDS (CDC 1993 Classification C).

Concurrent Medication:

Excluded:

Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.

Patients with the following prior conditions are excluded:

Clinically relevant hepatitis in the previous 6 months.

Prior Medication:

Excluded:

• Greater than 4 weeks of any nucleoside antiretroviral therapy.
• Previous therapy with an HIV protease inhibitor.
• Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
• Immunomodulating agents within 3 months prior to entry.

Prior Treatment:

Excluded:

Radiotherapy within 4 weeks prior to entry.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.