Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|