A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
2 other identifiers
interventional
N/A
1 country
12
Brief Summary
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
Trial Health
Trial Health Score
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12 active sites
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Trial Relationships
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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, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Primary or secondary prophylaxis for opportunistic infections.
- Patients must have:
- HIV infection.
- Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
- Cryptococcosis
- Pneumocystis carinii pneumonia
- Herpes zoster
- Histoplasmosis
- CMV
- Hepatic or renal disease
- Lymphoma.
- CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry.
- Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry.
- +1 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Intolerance to AZT.
- Current diagnosis of malignancy for which systemic therapy will be required during the study.
- Concurrent Medication:
- Excluded:
- Any other investigational drugs.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapy within 1 month prior to study entry.
- Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
- Antiretroviral agents other than AZT within 3 months prior to study entry.
- Required:
- AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90033, United States
UCI Med Ctr
Orange, California, 92668, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Johns Hopkins Hosp
Baltimore, Maryland, 212052196, United States
Boston City Hosp / FGH-1
Boston, Massachusetts, 02118, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Park Plaza Hosp
Houston, Texas, 77004, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, 53202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-11