To evaluate the effectiveness and toxicity of oral azithromycin and pyrimethamine as acute therapy for toxoplasmic encephalitis in AIDS patients. To assess the toxicity and effectiveness of azithromycin alone as maintenance therapy. Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus, alternative treatments are needed.
Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus, alternative treatments are needed. Patients with toxoplasmosis are given azithromycin at doses starting at the lowest dose for the first cohort, an intermediate dose for the second cohort, and a higher dose for the third cohort. Subsequent cohorts may receive azithromycin in increased dosage, if needed to determine the MTD. All patients also receive pyrimethamine. Folinic acid is also provided for as long as patients receive pyrimethamine. Patients are evaluated for clinical response to treatment at days 3, 7, and 14, and weekly for 6 weeks. Maintenance treatment with azithromycin continues for an additional 24 weeks. Patients who complete the study period without relapse or significant toxicity are offered continued therapy by the drug company and are followed for survival and relapse on a monthly basis for 1 year. After the MTD is determined, a subsequent cohort may be added for special studies.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
45
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States
Nassau County Med Ctr
East Meadow, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
SUNY - Stony Brook
Stony Brook, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States
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