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

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

Primary Purpose: Treatment

Condition ^ICMJE

Toxoplasmosis, Cerebral
HIV Infections

Intervention ^ICMJE

Drug: Atovaquone

Study Arms

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

13 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00001994

Other Study ID Numbers ^ICMJE

101A
02

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Glaxo Wellcome

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

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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