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Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
This study is ongoing, but not recruiting participants.
Sponsored by: Centaur Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002414
  Purpose

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 Intervention Phase
HIV Infections
Drug: CPI-1189
Phase II

MedlinePlus related topics: AIDS Dementia
Drug Information available for: CPI 1189
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Pharmacokinetics Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 60
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002414

Locations
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
Univ of Rochester / Strong Memorial Hosp
Rochester, New York, United States, 14620
Columbia Univ / Sergievsky Ctr Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Centaur Pharmaceuticals
Investigators
Study Chair: Clifford DB
  More Information

Publications:
Study ID Numbers: 289B, CPI001189-ADC01
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002414  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS Dementia Complex
Anti-HIV Agents

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
AIDS Dementia Complex
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Dementia
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009