A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
Paromomycin sulfate
Blood-Borne Infections+24
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy. Patients are randomized to receive either placebo or paromomycin for 3 weeks. After the initial double-blind phase, all patients receive open-label paromomycin for 3 weeks. Following 6 weeks of therapy, patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks, while complete responders continue receiving the original dose for an additional 3 weeks. Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved. Treatment continues for up to 25 weeks total. Patients are followed at weeks 1, 3, 4, 6, 7, and 9, and then at 2-4 week intervals.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Macrolides for disseminated Mycobacterium avium. Atovaquone for toxoplasmosis. Other antimicrobials for concurrent infections. Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea. Patients must have: Advanced HIV disease. Diarrhea presumptively caused by Cryptosporidia. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Hypersensitivity to aminoglycosides. Inability to swallow capsules. Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily). Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma). Concurrent Medication: Excluded during the first 9 weeks of study: Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum). Octreotide acetate (Sandostatin). Antidiarrheals other than those specifically allowed. Clarithromycin if initiated at 500 mg or higher or azithromycin if initiated at 600 mg or higher. Prior Medication: Excluded: Paromomycin at > 1 g/day for >= 14 days prior to study entry. Excluded within 14 days prior to study entry: Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum), with the exception of macrolides that are permitted for other indications. Octreotide acetate (Sandostatin).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Univ. of Miami AIDS CRS
Miami, United StatesNorthwestern University CRS
Chicago, United StatesRush Univ. Med. Ctr. ACTG CRS
Chicago, United States