A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Atevirdine mesylate
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Consent of parent, guardian, or person with power of attorney if less than 18 years of age. Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atevirdine mesylate|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents