Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002209
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
Sponsor:
Centaur Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Multiple Ascending Dose Pharmacokinetics of CPI-1189 LU 02-584 in Fasted HIV Infected Male Volunteers on Combined Reverse Transcriptase and Protease Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
1999-12
Last Known Status:
None
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 to give multiple doses of CPI-1189 to HIV-infected otherwise healthy males The study will also look at how CPI-1189 affects the levels of HIV T cells cells in the body that help fight infection and three anti-HIV drugs zidovudine lamivudine and indinavir in the blood
Advanced HIV infection can cause AIDS dementia brain damage due to HIV leading to losses 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 losses 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 losses of memory and muscle control CPI-1189 may be able to postpone AIDS dementia or slow it down
In this randomized double-blind study 48 HIV-infected otherwise healthy male volunteers receive either multiple-dose CPI-1189 or placebo by mouth for 15 consecutive days Each dosing group begins 6 weeks following the start of the preceding group Volunteers enter the study site the night before dosing on Days 1 and 15 and remain at the study site for 72 hours following dosing Throughout the study volunteers have physical exams and donate samples of blood urine cerebrospinal fluid and sperm
In this randomized double-blind study 48 HIV-infected otherwise healthy male volunteers receive either multiple-dose CPI-1189 or placebo by mouth for 15 consecutive days Each dosing group begins 6 weeks following the start of the preceding group Volunteers enter the study site the night before dosing on Days 1 and 15 and remain at the study site for 72 hours following dosing Throughout the study volunteers have physical exams and donate samples of blood urine cerebrospinal fluid and sperm
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-MAD01 | None | None | None |