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	Treatment or Intervention
Toxoplasmosis, Cerebral HIV Infections	Drug: Atovaquone

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  101A; 02
Record last reviewed:  March 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001994
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08