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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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-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 target trough levels.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 943055107
        • Stanford CRS
    • Colorado
      • Aurora, Colorado, United States, 80262
        • University of Colorado Hospital CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard University Hosp., Div. of Infectious Diseases, ACTU
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ. of Miami AIDS CRS
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • New York
      • Buffalo, New York, United States
        • SUNY - Buffalo, Erie County Medical Ctr.
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Unc Aids Crs
    • Ohio
      • Columbus, Ohio, United States
        • The Ohio State Univ. AIDS CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Fischl M
  • Study Chair: Para M

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

January 1, 1996

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 260
  • 11237 (Registry Identifier: DAIDS-ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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