ClinicalTrials.gg
CompletedNCT00002209Updated Jun 24, 2005

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

A Phase 1 interventional study of CPI-1189 in AIDS Dementia Complex and HIV Infections, sponsored by Centaur Pharmaceuticals. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Centaur Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • AIDS Dementia Complex
  • HIV Infections

Keywords

  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • AIDS Dementia Complex
  • Zidovudine
  • Lamivudine
  • Indinavir
  • Reverse Transcriptase Inhibitors
03

In context

AIDS Dementia Complex

41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 31 interventional studies indexed under AIDS Dementia Complex.

Browse AIDS Dementia Complex studies →

Lead sponsor

Centaur Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria

You may be eligible for this study if you:

  • Are an -positive man who is otherwise in good health.
  • Are 18-50 years old.
  • Have a of 75-500 cells/mm3.
  • Are currently taking zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
Double
Enrollment
48 participants

Interventions

  • DrugCPI-1189
06

Study locations

1 site
  • MDS Harris
    Phoenix, Arizona 85040, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002209
Lead sponsor
Centaur Pharmaceuticals
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 1999. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion