Journal Article

Paromomycin: No More Effective than Placebo for Treatment of Cryptosporidiosis in Patients with Advanced Human Immunodeficiency Virus Infection

Ross G. Hewitt, Constantin T. Yiannoutsos, Elizabeth S. Higgs, John T. Carey, P. Jan Geiseler, Rosemary Soave, Richard Rosenberg, Guillermo J. Vazquez, L. Joseph Wheat, Robert J. Fass, Zoran Antoninievic, Ann L. Walawander, Timothy P. Flanigan and John F. Bender

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 31, issue 4, pages 1084-1092
Published in print October 2000 | ISSN: 1058-4838
Published online October 2000 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/318155
Paromomycin: No More Effective than Placebo for Treatment of Cryptosporidiosis in Patients with Advanced Human Immunodeficiency Virus Infection

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To evaluate the efficacy of paromomycin for the treatment of symptomatic cryptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled trial before the widespread introduction of highly active antiretroviral therapy (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of ⩽150/mm3. Initially, 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomycin (500 mg q.i.d.) for an additional 21 days. Clinical definitions of response were measured by an average number of bowel movements per day in association with concurrent need for antidiarrheal agents that was lower than that before study entry. There was no treatment response during the placebo-controlled phase of the study according to protocol-defined criteria (P = .88). Three paromomycin recipients (17.6%) versus 2 placebo recipients (14.3%) responded completely. Rates of combined partial and complete responses in the paromomycin arm (8 out of 17, 47.1%) and the placebo arm (5 out of 14, 35.7%) of the study were also similar (P = .72). The clinical course of cryptosporidiosis was quite variable. Paromomycin was not shown to be more effective than placebo for the treatment of symptomatic cryptosporidial enteritis. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection.

Journal Article.  5402 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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