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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden. SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers. 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.

Key facts

Study ID

NCT00000810

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Expected to finish

1996-01-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford CRS — Stanford, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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