Status:
COMPLETED
Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 mo...
Detailed Description
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-nucleo...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 1996
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00000810
End Date
January 1 1996
Last Update
November 4 2021
Active Locations (10)
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1
Stanford CRS
Stanford, California, United States, 943055107
2
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
3
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, United States, 20059
4
Univ. of Miami AIDS CRS
Miami, Florida, United States, 331361013