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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety Study Primary Purpose: Treatment
Condition ^ICMJE	Toxoplasmosis, Cerebral HIV Infections
Intervention ^ICMJE	Drug: Atovaquone
Study Arm (s)	Not Provided
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)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States, Canada
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00001994
Other Study ID Numbers ^ICMJE	101A, 02
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1992
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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