A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Amprenavir (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
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.
Clinical Details
Official title: A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
Study design: Treatment, Parallel Assignment, Safety Study
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pacific Oaks Research, Beverly Hills, California 90211, United States
Dr Bruce Rashbaum, Washington, District of Columbia 20037, United States
Community Research Initiative of Central Florida, Maitland, Florida 32751, United States
Univ of Miami School of Medicine, Miami, Florida 33136, United States
Community Research Initiative of South Florida, Coral Gables, Florida 33146, United States
Chicago Ctr for Clinical Research, Chicago, Illinois 60610, United States
Community Research Initiative of New England, Brookline, Massachusetts 02445, United States
Saint Vincent's AIDS Ctr, New York, New York 10011, United States
Methodist Hosp, Memphis, Tennessee 38104, United States
Additional Information
Last updated: June 23, 2005
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