Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2000 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002414
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2000

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002414 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: CPI-1189
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Clifford DB, McArthur JC, Schifitto G, Kieburtz K, McDermott MP, Letendre S, Cohen BA, Marder K, Ellis RJ, Marra CM. A randomized clinical trial of CPI-1189 for HIV-associated cognitive-motor impairment. Neurology. 2002 Nov 26;59(10):1568-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002414
289B, CPI001189-ADC01
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Centaur Pharmaceuticals
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Study Chair: Clifford DB
NIH AIDS Clinical Trials Information Service
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP