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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV Infections; Toxoplasmosis, Cerebral

Treatments: Drug: Atovaquone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00001994

02

101A

Details and patient eligibility

About

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.