The Safety and Effectiveness of HBY 097 Used With or Without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
- Conditions
- HIV Infections
- Registration Number
- NCT00002357
- Lead Sponsor
- Hoechst Marion Roussel
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Stanford Univ School of Medicine
🇺🇸Stanford, California, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
New York Univ Med Ctr
🇺🇸New York, New York, United States
Houston Clinical Research Network
🇺🇸Houston, Texas, United States