HIV Infections Clinical Trial
Official title:
Randomized, Double-Blind, Parallel Group, Placebo Controlled, Tolerability, Safety and Pilot Efficacy Study of CPI-1189 in HIV Infected Individuals With Cognitive and Motor Impairment
The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients
with AIDS dementia.
Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of
memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.
Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of
memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.
Patients are randomized to receive either placebo or one of two oral doses of CPI-1189
daily. Patients are assessed for safety and tolerability during Weeks 2, 6, and 10. At Week
10, efficacy assessments are also made. For those who volunteer, a sample of cerebrospinal
fluid is obtained at baseline and at Week 10. Blood samples for CPI-1189 pharmacokinetic
trough measurements are taken at Weeks 2 and 10. The open-label phase starts at Week 11. At
Weeks 13 and 16, a safety evaluation is performed. At the end of the open-label phase, Week
22, a final set of safety and efficacy assessments and a blood sample for CPI-1189
pharmacokinetic trough measurement are obtained.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment
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