A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination. U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.

Key facts

Study ID

NCT00000803

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

471

Expected to finish

1997-03-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Required:
• PCP prophylaxis for patients with CD4 count <= 200 cells/mm3.
• Allowed:
• Topical antifungal agents.
• Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections.
• Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis).
• Acute or maintenance therapy for toxoplasmosis.
• Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection.
• rEPO and rG-CSF.
• Antibiotics for bacterial infections (except rifampin and rifabutin).
• Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone.
• Concurrent Treatment:
• Allowed for cutaneous Kaposi's sarcoma:
• Localized radiation therapy.
• Limited intralesional therapy.
• Patients must have:
• HIV infection.
• CD4 count 100 - 500 cells/mm3.
• Prior cumulative monotherapy of <= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma).
• Considered to be unlikely to comply with study requirements.
• Concurrent Medication:
• Excluded:
• Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF).
• Rifampin.
• Rifabutin.
• Terfenadine.
• Astemizole.
• Loratadine.
• Quinidine.
• Digitoxin.
• 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 intolerance to AZT at <= 600 mg/day or ddI at <= 400 mg/day or discontinuation of either drug for toxicity.
• History of intolerance to trifluoperazine or piperazine citrate (per amendment).
• History of pancreatitis.
• History of grade 2 or worse peripheral neuropathy.
• Unexplained temperature >= 38.5 C on any 7 days within the past 30 days.
• Chronic diarrhea on any 15 days during the past 30 days.
• Prior Medication:

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• USC CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, 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
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Washington U CRS — St Louis, Missouri, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• Cornell University A2201 — New York, New York, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• Memorial Sloan-Kettering Cancer Ctr. — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States

Full record on ClinicalTrials.gov

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