Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
Verified April 2000
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 2000
History of Changes
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.
Drug : CPI-1189
Primary Purpose: Treatment
|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:
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 older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- Have certain serious medical conditions, such as a mental disorder or an opportunistic
You will not be eligible for this study if you:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002414
Locations Show More
|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|
|Columbia Univ / Sergievsky Ctr Physicians and Surgeons|
|New York, New York, United States, 10032|
|Univ of Rochester / Strong Memorial Hosp|
|Rochester, New York, United States, 14620|
Sponsors and CollaboratorsCentaur Pharmaceuticals
|Study Chair:||Clifford DB|
|Responsible Party:||Centaur Pharmaceuticals|
|ClinicalTrials.gov Identifier:||NCT00002414 History of Changes|
|Other Study ID Numbers:||289B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS Dementia Complex
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 16, 2018
This information is provided by ClinicalTrials.gov.