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| ID | Type | Description | Link |
|---|---|---|---|
| CPI001189-ADC01 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPI-1189 | Drug |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford DB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzheimers Disease Research Ctr 0948 / UCSD | San Diego | California | 920930948 | United States | ||
| Northwestern Univ / Dept of Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12451199 | Background | 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. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015526 | AIDS Dementia Complex |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C406025 | CPI 1189 |
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Johns Hopkins Hosp / Dept of Neurology / Meyer 6109 | Baltimore | Maryland | 212877609 | United States |
| Washington Univ Sch of Med / Dept of Neurology | St Louis | Missouri | 63110 | United States |
| Columbia Univ / Sergievsky Ctr Physicians and Surgeons | New York | New York | 10032 | United States |
| Univ of Rochester / Strong Memorial Hosp | Rochester | New York | 14620 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |