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

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).