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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.

Study Type

Interventional

Enrollment

471

Phase

  • Phase 2

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

  • Puerto Rico
      • San Juan, Puerto Rico, 009365067
        • Puerto Rico-AIDS CRS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Therapeutics CRS
    • California
      • Los Angeles, California, United States
        • USC CRS
      • Palo Alto, California, United States
        • Stanford CRS
      • San Diego, California, United States
        • Ucsd, Avrc Crs
      • San Francisco, California, United States
        • Ucsf Aids Crs
    • Colorado
      • Aurora, Colorado, United States
        • 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
    • Hawaii
      • Honolulu, Hawaii, United States
        • Univ. of Hawaii at Manoa, Leahi Hosp.
      • Honolulu, Hawaii, United States, 96816
        • Queens Med. Ctr.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hosp. of Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - East Campus A0102 CRS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, ACTU
    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • St. Louis ConnectCare, Infectious Diseases Clinic
      • Saint Louis, Missouri, United States, 63110
        • Washington U CRS
    • New York
      • Buffalo, New York, United States, 14215
        • SUNY - Buffalo, Erie County Medical Ctr.
      • New York, New York, United States, 10021
        • Cornell University A2201
      • New York, New York, United States
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • New York, New York, United States
        • NY Univ. HIV/AIDS CRS
      • New York, New York, United States
        • Memorial Sloan-Kettering Cancer Ctr.
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ. of Cincinnati CRS
      • Cleveland, Ohio, United States
        • Case CRS
      • Columbus, Ohio, United States, 432101228
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Hosp. of the Univ. of Pennsylvania CRS
    • Washington
      • Seattle, Washington, United States, 981224304
        • University of Washington 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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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.

Exclusion Criteria

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:

Excluded:

  • Prior foscarnet as induction or maintenance therapy.
  • Prior U-90152.
  • Prior ddC or d4T.
  • Prior AZT/ddI in combination or taken separately at different times.
  • Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.).
  • Prior protease inhibitors (although patients from ACTG 282 are eligible).
  • HIV-1 vaccine within the past 21 days.
  • Acute treatment for a serious infection or for any opportunistic infection within the past 14 days.

Excluded within the past 30 days:

  • Interferon or interleukin.
  • Rifampin.
  • Rifabutin.
  • Terfenadine.
  • Astemizole.
  • Loratadine.
  • Recombinant EPO or G-CSF.
  • Hydroxyurea.
  • SPV-30.
  • Any other investigational drug.

Active drug or alcohol use.

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
  • Masking: Double

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: Pollard R
  • Study Chair: Friedland G

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)

March 1, 1997

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 261
  • 11238 (Registry Identifier: DAIDS-ES Registry Number)

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.

Clinical Trials on HIV Infections

Clinical Trials on Zidovudine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe