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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoechst Marion Roussel
• Treatments: Zidovudine

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.