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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002195

Run by

Glaxo Wellcome

People needed

290

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pacific Oaks Research — Beverly Hills, California, United States
• Dr Bruce Rashbaum — Washington D.C., District of Columbia, United States
• Community Research Initiative of South Florida — Coral Gables, Florida, United States
• Community Research Initiative of Central Florida — Maitland, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Chicago Ctr for Clinical Research — Chicago, Illinois, United States
• Community Research Initiative of New England — Brookline, Massachusetts, United States
• Saint Vincent's AIDS Ctr — New York, New York, United States
• Methodist Hosp — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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