A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
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.
2 other identifiers
interventional
290
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (9)
Pacific Oaks Research
Beverly Hills, California, 90211, United States
Dr Bruce Rashbaum
Washington D.C., District of Columbia, 20037, United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146, United States
Community Research Initiative of Central Florida
Maitland, Florida, 32751, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-11