Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CPI-1189
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring AIDS Dementia Complex, Anti-HIV Agents
Eligibility 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.
Sites / Locations
- Alzheimers Disease Research Ctr 0948 / UCSD
- Northwestern Univ / Dept of Neurology
- Johns Hopkins Hosp / Dept of Neurology / Meyer 6109
- Washington Univ Sch of Med / Dept of Neurology
- Columbia Univ / Sergievsky Ctr Physicians and Surgeons
- Univ of Rochester / Strong Memorial Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002414
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Centaur Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002414
Brief Title
Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centaur Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
AIDS Dementia Complex, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CPI-1189
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford DB
Official's Role
Study Chair
Facility Information:
Facility Name
Alzheimers Disease Research Ctr 0948 / UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
920930948
Country
United States
Facility Name
Northwestern Univ / Dept of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hosp / Dept of Neurology / Meyer 6109
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212877609
Country
United States
Facility Name
Washington Univ Sch of Med / Dept of Neurology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia Univ / Sergievsky Ctr Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester / Strong Memorial Hosp
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12451199
Citation
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.
Results Reference
background
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Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
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