Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
This trial is active, not recruiting.
|Trial size||60 participants|
|Trial identifier||NCT00002414, 289B, CPI001189-ADC01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|San Diego, CA||Alzheimers Disease Research Ctr 0948 / UCSD||no longer recruiting|
|Chicago, IL||Northwestern Univ / Dept of Neurology||no longer recruiting|
|Baltimore, MD||Johns Hopkins Hosp / Dept of Neurology / Meyer 6109||no longer recruiting|
|Saint Louis, MO||Washington Univ Sch of Med / Dept of Neurology||no longer recruiting|
|New York, NY||Columbia Univ / Sergievsky Ctr Physicians and Surgeons||no longer recruiting|
|Rochester, NY||Univ of Rochester / Strong Memorial Hosp||no longer recruiting|
|Endpoint classification||pharmacokinetics study|
Male or female participants at least 18 years old.
Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are at least 18 years old. - Have symptoms of AIDS dementia including forgetfulness, loss of concentration, slow mental processing, or a loss of muscle control. - Have been on stable anti-HIV drug therapy for the past 6 weeks (if you are taking anti-HIV drugs). Exclusion Criteria You will not be eligible for this study if you: - Have certain serious medical conditions, such as a mental disorder or an opportunistic (AIDS-related) infection.
|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|
|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.|
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