The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms

June 23, 2005 updated by: Hoechst Marion Roussel

A Multicenter, Randomized, Double-Blinded, Dose-Escalation Study Evaluating the Safety and Antiretroviral Activity of HBY 097 Versus HBY 097 Plus AZT in Patients With Asymptomatic or Mildly Symptomatic HIV Infection

To obtain preliminary information on the safety, tolerability, and antiretroviral activity of HBY 097 alone or in combination with zidovudine ( AZT ) versus AZT alone.

PER 1/19/96 AMENDMENT: AZT monotherapy arm was eliminated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive one of three doses of HBY 097 with or without AZT or AZT alone for 12 weeks (AZT monotherapy arm eliminated per 1/19/96 amendment). All patients at a given dose level of HBY 097 must be enrolled and adequate safety data obtained before escalation in subsequent patients begins. Additional patients are entered at the optimal dose of HBY 097. Patients are evaluated weekly for the first 4 weeks and then every 2 weeks for the next 9 weeks.

PER AMENDMENT: Enrollment to the lowest dose cohort is completed.

Study Type

Interventional

Enrollment

144

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

    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Stanford, California, United States, 943055107
        • Stanford Univ School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
    • New York
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
    • Texas
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network

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:

Allowed:

  • Treatment for opportunistic infection that develops on study.

Recommended:

  • PCP prophylaxis if CD4 count falls below 200 cells/mm3.

Patients must have:

  • HIV infection.
  • CD4 count 200 - 500 cells/mm3.
  • HIV-1 RNA PCR value of 10000 copies/ml or higher.
  • Asymptomatic or mildly symptomatic disease.
  • No past or current AIDS-defining event.
  • Consent of parent or guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Endocrine, hepatic, renal, or gastrointestinal disease.
  • Cardiovascular conduction disease.
  • Concomitant medical illness that may complicate study conduct or interpretation of results.
  • Other factors that may interfere with patient compliance.

Concurrent Medication:

Excluded:

  • Antiretroviral agents other than study drugs.
  • Oral contraceptives.
  • Cytotoxic chemotherapy.
  • Immunomodulators.
  • Antiproliferative agents.
  • Corticosteroids.
  • Anabolic steroids.
  • Estrogens.
  • Quinoxaline derivatives.

Concurrent Treatment:

Excluded:

  • Radiation therapy.

Patients with the following prior conditions are excluded:

  • History of hypersensitivity to quinoxaline derivatives or intolerance to AZT.
  • History of cardiovascular conduction disease.
  • Prior participation in this study or any study using HBY 097.
  • Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion.
  • History of thyroid disease.

Prior Medication:

Excluded at any time:

Prior non-nucleoside reverse transcriptase inhibitors.

Excluded within 30 days prior to study entry:

  • Any antiretroviral therapy.
  • Oral contraceptives.
  • Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons.
  • Cytotoxic chemotherapeutic agents.
  • Other investigational drugs.

Excluded within 6 months prior to study entry:

Immunotherapeutic vaccine.

Prior Treatment:

Excluded within 30 days prior to study entry:

  • Radiation therapy.
  • An experimental device. Current ethanol or illicit drug abuse.

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.

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 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 (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 1997

More Information

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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