Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
|ClinicalTrials.gov Identifier: NCT00002209|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|AIDS Dementia Complex HIV Infections||Drug: CPI-1189||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002209
|United States, Arizona|
|Phoenix, Arizona, United States, 85040|