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

Launched by PHARMACIA AND UPJOHN · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.