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| Sponsored by: |
Centaur Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002209 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
AIDS Dementia Complex HIV Infections |
Drug: CPI-1189 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| 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 |
| Estimated Enrollment: | 48 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Contacts and Locations More Information
| Study ID Numbers: | 289A, CPI001189-MAD01 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002209 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Dose-Response Relationship, Drug Drug Therapy, Combination AIDS Dementia Complex Zidovudine |
Lamivudine Indinavir Reverse Transcriptase Inhibitors |
|
Sexually Transmitted Diseases, Viral Anti-HIV Agents AIDS Dementia Complex Indinavir Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Central Nervous System Diseases Brain Diseases Antiviral Agents Immunologic Deficiency Syndromes Cognition Disorders |
Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Anti-Retroviral Agents Mental Disorders HIV Infections Sexually Transmitted Diseases Dementia Retroviridae Infections Delirium |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral AIDS Dementia Complex Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Brain Diseases Reverse Transcriptase Inhibitors Anti-Retroviral Agents Mental Disorders Therapeutic Uses Dementia Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
