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Sponsored by: |
Centaur Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002414 |
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 | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: CPI-1189 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
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 |
Estimated 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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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 | |
Univ of Rochester / Strong Memorial Hosp | |
Rochester, New York, United States, 14620 | |
Columbia Univ / Sergievsky Ctr Physicians and Surgeons | |
New York, New York, United States, 10032 |
Study Chair: | Clifford DB |
Study ID Numbers: | 289B, CPI001189-ADC01 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002414 |
Health Authority: | United States: Food and Drug Administration |
AIDS Dementia Complex Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral AIDS Dementia Complex HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Dementia Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |