We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00001994
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
  • Toxoplasmosis, Cerebral
  • HIV Infections
Drug: Atovaquone
Not Provided
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.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00001994
101A
02
Not Provided
Not Provided
Not Provided
Not Provided
Glaxo Wellcome
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
March 1992

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP