Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002414
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia
Sponsor:
Centaur Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2000-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPI001189-ADC01 | None | None | None |