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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001994
• Other study ID #: 101A
• Secondary ID: 02
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1992
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Encephalitis
• HIV Infections
• Immunologic Deficiency Syndromes
• Toxoplasmosis
• Toxoplasmosis, Cerebral

Intervention

Drug:
• Atovaquone

Locations

Country	Name	City	State
Canada	Southern Alberta HIV Clinic / Foothills Hosp	Calgary	Alberta
Canada	Dr Emil Toma / Hotel Dieu de Montreal	Montreal	Quebec
Canada	Wellesley Hosp	Toronto	Ontario
Canada	Dr Julio S G Montaner	Vancouver	British Columbia
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Infectious Disease Research Consortium of Georgia	Atlanta	Georgia
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Gathe, Joseph, M.D.	Houston	Texas
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Regional Med Ctr at Memphis	Memphis	Tennessee
United States	Beth Israel Med Ctr	New York	New York
United States	Harlem Hosp Ctr	New York	New York
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	Infectious Disease Med Group	Oakland	California
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Davies Med Ctr	San Francisco	California
United States	San Francisco Gen Hosp	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Canada, 

References & 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)