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

Genetics Home Reference related topics:   Neurologic Diseases  

MedlinePlus related topics:   AIDS   Encephalitis   Toxoplasmosis  

ChemIDplus related topics:   Pyrimethamine   Atovaquone   Sulfadiazine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
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
  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

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

Locations
United States, California
San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
Davies Med Ctr    
      San Francisco, California, United States, 94114
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
UCSF - San Francisco Gen Hosp    
      San Francisco, California, United States, 94110
Infectious Disease Med Group    
      Oakland, California, United States, 94609
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
United States, California
San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
Davies Med Ctr    
      San Francisco, California, United States, 94114
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
UCSF - San Francisco Gen Hosp    
      San Francisco, California, United States, 94110
Infectious Disease Med Group    
      Oakland, California, United States, 94609
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
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)

Study ID Numbers:   101A, 02
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00001994
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  

Study placed in the following topic categories:
Pyrimethamine
Bacterial Infections
Protozoan Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Toxoplasmosis, Cerebral
Acquired Immunodeficiency Syndrome
Central Nervous System Diseases
Brain Diseases
Encephalitis
Toxoplasmosis
Immunologic Deficiency Syndromes
Folic Acid
Mycoses
Atovaquone
Central Nervous System Infections
HIV Infections
Abscess
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases

Additional relevant MeSH terms:
Brain Abscess
Abscess
Anti-Infective Agents
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Central Nervous System Viral Diseases
Infection
Central Nervous System Parasitic Infections
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Parasitic Diseases
Coccidiostats
RNA Virus Infections
Immune System Diseases
Coccidiosis
Nervous System Diseases
Enzyme Inhibitors
Folic Acid Antagonists

Source: National Library of Medicine (NLM) June 26, 2008