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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect 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 o...

Gender

ALL

Eligibility 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).

Trial Officials