The Safety and Effectiveness of 935U83 in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002338
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.
- Detailed Description
Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 (7)
Goodgame Med Group
🇺🇸Maitland, Florida, United States
ViRx Inc
🇺🇸San Francisco, California, United States
Univ of Pittsburgh Med School
🇺🇸Pittsburgh, Pennsylvania, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Cincinnati / Holmes Hosp
🇺🇸Cincinnati, Ohio, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States