Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
- Conditions
- HIV Infections
- Registration Number
- NCT00002414
- Lead Sponsor
- Centaur Pharmaceuticals
- Brief Summary
The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients with AIDS dementia.
Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.
- Detailed Description
Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.
Patients are randomized to receive either placebo or one of two oral doses of CPI-1189 daily. Patients are assessed for safety and tolerability during Weeks 2, 6, and 10. At Week 10, efficacy assessments are also made. For those who volunteer, a sample of cerebrospinal fluid is obtained at baseline and at Week 10. Blood samples for CPI-1189 pharmacokinetic trough measurements are taken at Weeks 2 and 10. The open-label phase starts at Week 11. At Weeks 13 and 16, a safety evaluation is performed. At the end of the open-label phase, Week 22, a final set of safety and efficacy assessments and a blood sample for CPI-1189 pharmacokinetic trough measurement are obtained.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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)
Washington Univ Sch of Med / Dept of Neurology
🇺🇸Saint Louis, Missouri, United States
Alzheimers Disease Research Ctr 0948 / UCSD
🇺🇸San Diego, California, United States
Johns Hopkins Hosp / Dept of Neurology / Meyer 6109
🇺🇸Baltimore, Maryland, United States
Northwestern Univ / Dept of Neurology
🇺🇸Chicago, Illinois, United States
Univ of Rochester / Strong Memorial Hosp
🇺🇸Rochester, New York, United States
Columbia Univ / Sergievsky Ctr Physicians and Surgeons
🇺🇸New York, New York, United States