Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)

Inclusion Criteria Concurrent Medication: Allowed: PCP prophylaxis. Topical antifungal agents, clotrimazole troches, nystatin oral suspension, topical ketoconazole, and oral fluconazole. Acyclovir (<= 1000 mg/day) as maintenance therapy for herpes simplex virus. Recombinant erythropoietin and G-CSF. Antibiotics for bacterial infections, unless specifically excluded. Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics. Antacids. Patients must have: HIV-1 infection. CD4 count 200 - 500 cells/mm3. Either no prior antiretroviral therapy or discontinued AZT monotherapy 3 or more weeks prior to study entry. NOTE: Half of patients should be antiretroviral naive. Prior Medication: Allowed: Prior AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy other than minimal Kaposi's sarcoma. Concurrent Medication: Excluded: Rifabutin. Rifampin. Terfenadine. Astemizole. Loratadine. Trifluoperazine. Piperazine citrate. Any acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection. Non-study antiretroviral therapies, interferons, biologic response modifiers, and HIV vaccines. Systemic corticosteroids for more than 21 consecutive days. Foscarnet. Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: History of pancreatitis (in patients who received prior AZT). History of grade 2 or worse peripheral neuropathy (in patients who received prior AZT). History of hypersensitivity to BHAP compounds (e.g., trifluoperazine - Stelazine, piperazine citrate - Antepar). Prior Medication: Excluded within 30 days prior to study entry: Any investigational medication. Interferon. Interleukin. Rifabutin. Rifampin. Terfenadine. Astemizole. Loratadine. Trifluoperazine. Piperazine citrate. Excluded at any time: Prior ddI, ddC, d4T, or 3TC. Prior foscarnet. Prior BHAP compound or other non-nucleoside RT inhibitor. Active substance abuse interfering with compliance.