NCT00002218

Brief Summary

To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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

July 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Dose-Response Relationship, DrugAnti-HIV Agents

Interventions

CI-1012DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
  • CD4 T cell count less than or equal to 200 mm3.
  • HIV-1 RNA greater than or equal to 5,000 copies/mL.

You may not qualify if:

  • Prior Medication:
  • Excluded:
  • Anti-HIV treatment within 8 weeks prior to entry.
  • Systemic steroids within 4 weeks prior to entry.
  • Prior Treatment:
  • Excluded:
  • Treatment with anticancer agents within 4 weeks prior to study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

ViRx Inc

Palm Springs, California, 92262, United States

Location

ViRx Inc

San Francisco, California, 94109, United States

Location

Central Florida Research Initiative

Maitland, Florida, 32751, United States

Location

Natl Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Univ of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Univ of Utah Med School / Clinical Trials Ctr

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
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: 1998-07

Locations

US(6)