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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Centaur Pharmaceuticals


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002209

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1999
History of Changes
Purpose

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: Masking: Double
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 48

Detailed 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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).

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002209

Locations

United States, Arizona
MDS Harris
Phoenix, Arizona, United States, 85040

Sponsors and Collaborators

Centaur Pharmaceuticals
More Information

More Information


Responsible Party: Centaur Pharmaceuticals  
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  

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:
HIV Infections
Dementia
AIDS Dementia Complex

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.