HIV Infections Clinical Trial
Official title:
A Dose-Escalation, Phase I/II Study of Oral Azithromycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
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.
;
Primary Purpose: Treatment
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