A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following conditions or symptoms are excluded:
• •History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue.
• •Coma.
• •More than 72 hours of treatment for current episode of toxoplasmic encephalitis prior to study entry.
• •Central nervous system (CNS) lymphoma.
• •Cerebral Kaposi's sarcoma.
• •Active hepatitis or clinical jaundice.
• •History of serious hypersensitivity or intolerance to any of the study drugs.
• •Serum or cerebrospinal fluid (CSF) positive for cryptococcus antigen or culture.
• •Malignancies requiring use of cytotoxic chemotherapy.
• •Inability to take oral therapy reliably.
• •Malabsorption syndrome.
• •Concurrent Medication:
• •Excluded:
• •Opportunistic infection requiring either acute treatment or maintenance therapy with azithromycin, erythromycin or other macrolides, sulfonamides, amphotericin, dapsone, ganciclovir, antifolates, and other investigational agents except erythropoietin. For first 6 weeks of treatment, patients may not receive treatment with erythromycin (or other macrolides), sulfonamides, immunomodulators with the exception of alpha interferon, lymphocyte replacement, cytotoxic chemotherapy, dapsone, ganciclovir, rifampicin, coumadin, antiretrovirals, and investigational agents other than erythropoietin.
• •Patients with the following are excluded:
• •Negative HIV antibodies by a federally licensed ELISA, unless there is documentation of a previously positive HIV culture or p24 antigen.
• •Infections of the central nervous system.
• •Malignancies requiring the use of cytotoxic chemotherapy.
• •Any medical or social condition that, in the opinion of the investigator, would adversely affect participation and/or compliance in this study.