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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.

Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks.

PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three targ...

Gender

ALL

Eligibility criteria

• • 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.