NCT00002209

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

AIDS Dementia ComplexHIV Infections

Keywords

Dose-Response Relationship, DrugDrug Therapy, CombinationAIDS Dementia ComplexZidovudineLamivudineIndinavirReverse Transcriptase Inhibitors

Interventions

CPI-1189DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Harris

Phoenix, Arizona, 85040, United States

Location

MeSH Terms

Conditions

AIDS Dementia ComplexHIV Infections

Interventions

CPI 1189

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-12

Locations

US(1)