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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Page 1 of 3 (10 locations)

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