A Study of CI-1012 in HIV-Infected Patients

June 23, 2005 updated by: Parke-Davis

A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

Study Type

Interventional

Enrollment

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palm Springs, California, United States, 92262
        • ViRx Inc
      • San Francisco, California, United States, 94109
        • ViRx Inc
    • Florida
      • Maitland, Florida, United States, 32751
        • Central Florida Research Initiative
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Natl Institutes of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

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

Exclusion Criteria

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parke-Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278A
  • 1012-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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