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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002414
• Other study ID #: 289B
• Secondary ID: CPI001189-ADC01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• CPI-1189

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp / Dept of Neurology / Meyer 6109	Baltimore	Maryland
United States	Northwestern Univ / Dept of Neurology	Chicago	Illinois
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	Washington Univ Sch of Med / Dept of Neurology	Saint Louis	Missouri
United States	Alzheimers Disease Research Ctr 0948 / UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Centaur Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation