Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
|ClinicalTrials.gov Identifier: NCT00002414|
Recruitment Status : Unknown
Verified April 2000 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: CPI-1189||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Official Title:||Randomized, Double-Blind, Parallel Group, Placebo Controlled, Tolerability, Safety and Pilot Efficacy Study of CPI-1189 in HIV Infected Individuals With Cognitive and Motor Impairment|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002414
|United States, California|
|Alzheimers Disease Research Ctr 0948 / UCSD|
|San Diego, California, United States, 920930948|
|United States, Illinois|
|Northwestern Univ / Dept of Neurology|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Johns Hopkins Hosp / Dept of Neurology / Meyer 6109|
|Baltimore, Maryland, United States, 212877609|
|United States, Missouri|
|Washington Univ Sch of Med / Dept of Neurology|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia Univ / Sergievsky Ctr Physicians and Surgeons|
|New York, New York, United States, 10032|
|Univ of Rochester / Strong Memorial Hosp|
|Rochester, New York, United States, 14620|
|Study Chair:||Clifford DB|