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
2 other identifiers
interventional
N/A
2 countries
22
Brief Summary
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.
Trial Health
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22 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (22)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Infectious Disease Med Group
Oakland, California, 94609, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103, United States
Gathe, Joseph, M.D.
Houston, Texas, 77004, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
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
Related Publications (1)
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)
BACKGROUND