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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy  Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
For Condition: AIDS Dementia Complex,HIV Infections
Status: Completed
Sponsor(s): Centaur Pharmaceuticals ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Male
Protocol Entry Criteria: 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).
Total Enrollment: 48
Location and Contact Information:
MDS Harris
Phoenix, Arizona, 85040
United States
Additional Information:
Study ID Numbers: 289A; CPI001189-MAD01
Study Start Date:
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002209
Other Hiv Infections Studies:
1. Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
2. A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
3. Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
4. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
5. A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
Related Studies:
Other HIV Infections Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
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