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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001994
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1992
  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: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
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
Davies Med Ctr
San Francisco, California, United States, 94114
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
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
Harlem Hosp Ctr
New York, New York, United States, 10037
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
Beth Israel Med Ctr
New York, New York, United States, 10003
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, Alberta
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta, Canada
Canada, British Columbia
Dr Julio S G Montaner
Vancouver, British Columbia, Canada
Canada, Ontario
Wellesley Hosp
Toronto, Ontario, Canada
Canada, Quebec
Dr Emil Toma / Hotel Dieu de Montreal
Montreal, Quebec, Canada
Sponsors and Collaborators
Glaxo Wellcome
  More Information

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)

ClinicalTrials.gov Identifier: NCT00001994     History of Changes
Other Study ID Numbers: 101A, 02
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Toxoplasmosis
AIDS-Related Opportunistic Infections
Naphthoquinones
Encephalitis
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Encephalitis
Immunologic Deficiency Syndromes
Toxoplasmosis
Toxoplasmosis, Cerebral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Central Nervous System Viral Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Coccidiosis
Protozoan Infections
Parasitic Diseases
Brain Abscess
Abscess
Suppuration
Infection
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Pyrimethamine
Atovaquone

ClinicalTrials.gov processed this record on July 23, 2014