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 - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Toxoplasmosis, Cerebral HIV Infections
Intervention ^ICMJE	Drug: Atovaquone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
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
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00001994
Responsible Party
Study ID Numbers ^ICMJE	101A, 02
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE
Investigators ^ICMJE
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