A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
NCT ID: NCT00002195
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
290 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Amprenavir
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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PROA3001
Identifier Type: -
Identifier Source: secondary_id
264D
Identifier Type: -
Identifier Source: org_study_id