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

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility 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.