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AIDS. 2001 Mar 30;15(5):583-9.

Dose-escalation, phase I/II study of azithromycin and pyrimethamine for the treatment of toxoplasmic encephalitis in AIDS.

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1
Department of Medicine, Mt Sinai Medical Center, New York, NY 10029, USA.

Abstract

OBJECTIVE:

To assess the safety, tolerance and activity of increasing doses of azithromycin in combination with pyrimethamine for the treatment of toxoplasmic encephalitis (TE) in patients with AIDS.

DESIGN:

A phase I/II dose-escalation study of oral azithromycin in combination with pyrimethamine.

SETTING:

Eight clinical sites in the United States.

PATIENTS:

Forty-two adult HIV-infected patients with confirmed or presumed acute TE.

METHODS:

Patients were enrolled into three successive cohorts receiving azithromycin 900, 1200 and 1500 mg a day with pyrimethamine as induction therapy. The induction period was 6 weeks followed by 24 weeks of maintenance therapy.

MAIN OUTCOME MEASURES:

Patient response was evaluated clinically and radiologically.

RESULTS:

Of the 30 evaluable patients, 20 (67%) responded to therapy during the induction period. Ten experienced disease progression. Of the 15 patients who received maintenance therapy, seven (47%) relapsed. Six patients discontinued treatment during the induction period as a result of reversible toxicities. Treatment-terminating adverse events occurred most frequently among the patients receiving the 1500 mg dose.

CONCLUSION:

The combination of azithromycin (900-1200 mg a day) and pyrimethamine may be useful as an alternative therapy for TE among patients intolerant of sulfonamides and clindamycin, but maintenance therapy with this combination was associated with a high relapse rate. The combination was safe, but low-grade adverse events were common.

[Indexed for MEDLINE]

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