Search / Trial NCT00002357

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

Launched by HOECHST MARION ROUSSEL · Aug 30, 2001

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Therapy, Combination Aids Related Complex Antiviral Agents Zidovudine

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • • 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.

About Hoechst Marion Roussel

Hoechst Marion Roussel, a prominent global pharmaceutical company, specializes in the research, development, and commercialization of innovative therapies across various therapeutic areas, including oncology, cardiovascular, and infectious diseases. With a commitment to advancing medical science and improving patient outcomes, the company leverages cutting-edge technology and a robust pipeline of clinical trials to bring new treatments to market. Hoechst Marion Roussel is dedicated to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and efficacy of its products while fostering collaboration with healthcare professionals and research institutions worldwide.

Locations

Los Angeles, California, United States

Washington, District Of Columbia, United States

Augusta, Georgia, United States

Houston, Texas, United States

Stanford, California, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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