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.
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
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
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
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New York Univ Med Ctr
New York, New York, United States
Houston Clinical Research Network
Houston, Texas, United States