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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Glaxo Wellcome


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00001994

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: March 1992
History of Changes
Purpose

Purpose

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.

Condition Intervention
Toxoplasmosis, Cerebral
HIV Infections

Drug : Atovaquone

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001994

Locations

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

Sponsors and Collaborators

Glaxo Wellcome
More Information

More Information


Responsible Party: Glaxo Wellcome  
ClinicalTrials.gov Identifier: NCT00001994   History of Changes  
Other Study ID Numbers: 101A  
  02  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Toxoplasmosis
AIDS-Related Opportunistic Infections
Naphthoquinones
Encephalitis
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Encephalitis
Toxoplasmosis
Toxoplasmosis, Cerebral
Pyrimethamine
Atovaquone
Sulfadiazine

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.