Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoechst Marion Roussel
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.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
