Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002209
• Other study ID #: 289A
• Secondary ID: CPI001189-MAD01
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS Dementia Complex
• HIV Infections

Intervention

Drug:
• CPI-1189

Locations

Country	Name	City	State
United States	MDS Harris	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Centaur Pharmaceuticals

Country where clinical trial is conducted

United States,