Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
NCT ID: NCT00002414
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
Brief Summary
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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
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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.
Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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CPI-1189
Eligibility Criteria
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Inclusion Criteria
* 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
* Have certain serious medical conditions, such as a mental disorder or an opportunistic (AIDS-related) infection.
18 Years
ALL
No
Sponsors
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Centaur Pharmaceuticals
INDUSTRY
Principal Investigators
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Clifford DB
Role: STUDY_CHAIR
Locations
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Alzheimers Disease Research Ctr 0948 / UCSD
San Diego, California, United States
Northwestern Univ / Dept of Neurology
Chicago, Illinois, United States
Johns Hopkins Hosp / Dept of Neurology / Meyer 6109
Baltimore, Maryland, United States
Washington Univ Sch of Med / Dept of Neurology
St Louis, Missouri, United States
Columbia Univ / Sergievsky Ctr Physicians and Surgeons
New York, New York, United States
Univ of Rochester / Strong Memorial Hosp
Rochester, New York, United States
Countries
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References
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Clifford DB, McArthur JC, Schifitto G, Kieburtz K, McDermott MP, Letendre S, Cohen BA, Marder K, Ellis RJ, Marra CM; Neurologic AIDS Research Consortium. A randomized clinical trial of CPI-1189 for HIV-associated cognitive-motor impairment. Neurology. 2002 Nov 26;59(10):1568-73. doi: 10.1212/01.wnl.0000034177.47015.da.
Other Identifiers
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CPI001189-ADC01
Identifier Type: -
Identifier Source: secondary_id
289B
Identifier Type: -
Identifier Source: org_study_id