The Safety and Effectiveness of 935U83 in HIV-Infected Patients

June 23, 2005 updated by: Glaxo Wellcome

A Phase I Trial to Evaluate the Safety, Tolerance, and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection

To assess the safety, tolerance, and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection. To obtain preliminary evidence of antiretroviral activity of 935U83. To prospectively evaluate the emergence of in vitro drug resistance. To determine the effects of 935U83 dosing on CD4+ cell counts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients (10 per dose level) are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks. Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose. If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level, the dose regimens may be adjusted.

Study Type

Interventional

Enrollment

40

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
      • San Francisco, California, United States, 94103
        • ViRx Inc
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Maitland, Florida, United States, 32751
        • Goodgame Med Group
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Hosp
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Univ of Cincinnati / Holmes Hosp
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • Univ of Pittsburgh Med School

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Recommended:

  • PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation.

Allowed:

  • Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.

Patients must have:

  • HIV infection.
  • CD4 count 200 - 500 cells/mm3.
  • No history of or current AIDS-defining indicator disease by CDC criteria.
  • No antiretroviral therapy within the past 6 months.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patient with the following symptoms or conditions are excluded:

  • Current evidence of chronic hepatitis of any etiology.
  • Seropositivity for HBsAg or hepatitis C virus by second generation ELISA.

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapy.
  • Other antiretroviral drugs.
  • Immunomodulators.
  • Foscarnet.
  • GM-CSF or G-CSF.
  • Erythropoietin.

Concurrent Treatment:

Excluded:

  • Radiation therapy.

Patients with the following prior conditions are excluded:

History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years.

Prior Medication:

Excluded within the past 6 months:

  • Any antiretroviral therapy.
  • HIV immunotherapeutic vaccine.

Excluded within the past 4 weeks:

  • Cytotoxic chemotherapy.
  • Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon.

Prior Treatment:

Excluded within the past 4 weeks:

  • Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.

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

Glaxo Wellcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 237A
  • 02

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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