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
NCT ID: NCT00000771
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
1996-09-30
Brief Summary
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In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Paromomycin sulfate
Eligibility Criteria
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Inclusion Criteria
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
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).
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Carey J
Role: STUDY_CHAIR
Locations
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USC CRS
Los Angeles, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Weiss Memorial Hosp.
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Cornell University A2201
New York, New York, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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References
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Hewitt RG, Yiannoutsos CT, Higgs ES, Carey JT, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat LJ, Fass RJ, Antoninievic Z, Walawander AL, Flanigan TP, Bender JF. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trial Group. Clin Infect Dis. 2000 Oct;31(4):1084-92. doi: 10.1086/318155. Epub 2000 Oct 25.
Other Identifiers
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11167
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 192
Identifier Type: -
Identifier Source: org_study_id