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	Treatment or Intervention	Phase
HIV Infections	Drug: CPI-1189	Phase II

Further Study Details: 

Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Alzheimers Disease Research Ctr 0948 / UCSD, San Diego,  California,  920930948,  United States
Illinois
      Northwestern Univ / Dept of Neurology, Chicago,  Illinois,  60611,  United States
Maryland
      Johns Hopkins Hosp / Dept of Neurology / Meyer 6109, Baltimore,  Maryland,  212877609,  United States
Missouri
      Washington Univ Sch of Med / Dept of Neurology, Saint Louis,  Missouri,  63110,  United States
New York
      Univ of Rochester / Strong Memorial Hosp, Rochester,  New York,  14620,  United States
      Columbia Univ / Sergievsky Ctr Physicians and Surgeons, New York,  New York,  10032,  United States

Study chairs or principal investigators

Clifford DB,  Study Chair

Study ID Numbers:  289B; CPI001189-ADC01
Record last reviewed:  April 2000
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002414
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08