HIV Infections Clinical Trial
Official title:
A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in
individuals who are coinfected with HIV and latent Toxoplasma gondii.
Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard
treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine.
Continuous treatment is necessary to prevent recurrence of the disease, but constant use of
pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be
effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates
pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91
amendment, clindamycin arm was discontinued).
Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard
treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine.
Continuous treatment is necessary to prevent recurrence of the disease, but constant use of
pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be
effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates
pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91
amendment, clindamycin arm was discontinued).
Patients are randomized to receive pyrimethamine or placebo three times a week. All patients
must be on aerosolized pentamidine, trimethoprim / sulfamethoxazole (T/S), or dapsone for
Pneumocystis carinii pneumonia prophylaxis. Patients will be evaluated bi-weekly for the
first month and every other month thereafter for at least 24 months.
;
Intervention Model: Parallel Assignment, Primary Purpose: Prevention
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