Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
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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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Double-Blind Primary Purpose: Treatment |
| 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:
- Are an HIV-positive man who is otherwise in good health.
- Are 18-50 years old.
- Have a CD4 count of 75-500 cells/mm3.
- Are currently taking zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00002209
| United States, Arizona | |
| MDS Harris | |
| Phoenix, Arizona, United States, 85040 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002209 History of Changes |
| Other Study ID Numbers: | 289A, CPI001189-MAD01 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Dose-Response Relationship, Drug Drug Therapy, Combination AIDS Dementia Complex Zidovudine |
Lamivudine Indinavir Reverse Transcriptase Inhibitors |
Additional relevant MeSH terms:
|
AIDS Dementia Complex Acquired Immunodeficiency Syndrome Dementia HIV Infections Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Mental Disorders Nervous System Diseases RNA Virus Infections Retroviridae Infections |
Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Reverse Transcriptase Inhibitors Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015