Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pharmacia and Upjohn
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.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
Consent of parent, guardian, or person with power of attorney if less than 18 years of age.
You may not be 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.
