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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Toxoplasmosis, Cerebral, HIV Infections

Intervention / Treatment
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* Drug: Atovaquone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atovaquone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toxoplasmosis, AIDS-Related Opportunistic Infections, Naphthoquinones, Encephalitis, Acquired Immunodeficiency Syndrome