Paromomycin: No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection

To evaluate the efficacy of paromomycin for the treatment of symptomatic cr yptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled tria l before the widespread introduction of highly active antiretroviral therap y (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of less than or equal to 150/mm(3) . Initially 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomyc in (500 mg q.i.d.) for an additional 21 days. Clinical definitions of respo nse were measured by an average number of bowel movements per day in associ ation with concurrent need for antidiarrheal agents that was lower than tha t before study entry. There was no treatment response during the placebo-co ntrolled 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 t he paromomycin arm (8 out of 17, 47.1%) and the placebo arm (5 out of 14, 3 5.7%) of the study were also similar (P = .72). The clinical course of cryp tosporidiosis was quite variable. Paromomycin was not shown to be more effe ctive than placebo for the treatment of symptomatic cryptosporidial enterit is. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection.