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

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.