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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002209
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1999
  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

Resource links provided by NLM:


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

Estimated 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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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

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:
Acquired Immunodeficiency Syndrome
AIDS Dementia Complex
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
Retroviridae Infections
RNA Virus 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 October 21, 2014