A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine

June 23, 2005 updated by: Glaxo Wellcome
To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate conventional therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Southern Alberta HIV Clinic / Foothills Hosp
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Dr Julio S G Montaner
    • Ontario
      • Toronto, Ontario, Canada
        • Wellesley Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Dr Emil Toma / Hotel Dieu de Montreal
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Oakland, California, United States, 94609
        • Infectious Disease Med Group
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30345
        • Infectious Disease Research Consortium of Georgia
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hosp
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Ctr
      • New York, New York, United States, 10011
        • Saint Vincent's Hosp and Med Ctr
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional Med Ctr at Memphis
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77004
        • Gathe, Joseph, M.D.
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have the following:

  • Presumptive diagnosis of AIDS.
  • Cerebral toxoplasmosis.
  • Expected survival of at least four weeks without therapy.
  • Willing and able to give informed consent.

Prior Medication:

Allowed:

  • Pyrimethamine-sulfonamide.
  • Clindamycin-sulfonamide.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Significant emotional disorder or psychosis.
  • Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
  • Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
  • Ensure Plus) or pulverized form through a nasogastric tube.
  • Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Concurrent Medication:

Excluded:

  • Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
  • First three weeks of treatment:
  • Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
  • ddI,ddC).

Patients with the following are excluded:

  • Significant emotional disorder or psychosis.
  • Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
  • Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
  • Ensure Plus) or pulverized form through a nasogastric tube.
  • Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

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

  • Masur H, et al. 566C80 is effective as salvage treatment for toxoplasma encephalitis. Int Conf AIDS. 1991 Jun 16-21;7(2):30 (abstract no WB31)

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

March 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101A
  • 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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