NCT00002196

Brief Summary

The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

4 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

Dose-Response Relationship, DrugAdministration, OralDrug Administration ScheduleCD4 Lymphocyte CountAnti-HIV Agents

Interventions

CI-1012DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have:
  • Serologic evidence of infection with HIV-1.
  • CD4+ cell count \>= 200 cells/mm3.
  • HIV-1 RNA \>= 10,000 copies/ml.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions are excluded:
  • Viral, fungal, or bacterial infection requiring therapy other than topical medications.
  • Concurrent Medication:
  • Excluded:
  • Prophylactic systematic antibacterial, antifungal or antiviral agents.
  • Antiretroviral therapy. NOTE:
  • Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.
  • Prior Medication:
  • Excluded:
  • Experimental therapy for \>= 4 weeks prior to initiation of study medication.
  • Antiretroviral treatment for 3 weeks prior to initiation of study medication.
  • Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

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
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(4)