A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002218
- Lead Sponsor
- Parke-Davis
- Brief Summary
To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.
- Detailed Description
Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.
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 (5)
Natl Institutes of Health
🇺🇸Bethesda, Maryland, United States
Central Florida Research Initiative
🇺🇸Maitland, Florida, United States
Univ of Michigan
🇺🇸Ann Arbor, Michigan, United States
ViRx Inc
🇺🇸San Francisco, California, United States
Univ of Utah Med School / Clinical Trials Ctr
🇺🇸Salt Lake City, Utah, United States