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
Trial Information
Current as of January 15, 2025
Completed
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
Carey J
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Saint Louis, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
San Juan, , Puerto Rico
Chicago, Illinois, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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