NCT00002414

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

AIDS Dementia ComplexAnti-HIV Agents

Interventions

CPI-1189DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alzheimers Disease Research Ctr 0948 / UCSD

San Diego, California, 920930948, United States

Location

Northwestern Univ / Dept of Neurology

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hosp / Dept of Neurology / Meyer 6109

Baltimore, Maryland, 212877609, United States

Location

Washington Univ Sch of Med / Dept of Neurology

St Louis, Missouri, 63110, United States

Location

Columbia Univ / Sergievsky Ctr Physicians and Surgeons

New York, New York, 10032, United States

Location

Univ of Rochester / Strong Memorial Hosp

Rochester, New York, 14620, United States

Location

Related 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. doi: 10.1212/01.wnl.0000034177.47015.da.

    PMID: 12451199BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS Dementia Complex

Interventions

CPI 1189

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Clifford DB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2000-04

Locations

US(6)