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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002357

Run by

Hoechst Marion Roussel

People needed

144

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Stanford Univ School of Medicine — Stanford, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Med College of Georgia — Augusta, Georgia, United States
• New York Univ Med Ctr — New York, New York, United States
• Houston Clinical Research Network — Houston, Texas, United States

Full record on ClinicalTrials.gov

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