- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000771
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
To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit.
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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San Juan, Puerto Rico
- Puerto Rico-AIDS CRS
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California
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Los Angeles, California, United States
- USC CRS
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Florida
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Miami, Florida, United States, 33136
- Univ. of Miami AIDS CRS
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University CRS
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Chicago, Illinois, United States, 60612
- Rush Univ. Med. Ctr. ACTG CRS
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Chicago, Illinois, United States, 60640
- Weiss Memorial Hosp.
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Indianapolis, Indiana, United States, 46202
- Methodist Hosp. of Indiana
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Missouri
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Saint Louis, Missouri, United States
- Washington U CRS
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New York
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Buffalo, New York, United States, 14215
- SUNY - Buffalo, Erie County Medical Ctr.
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New York, New York, United States, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, United States, 10021
- Cornell University A2201
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Ohio
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Cincinnati, Ohio, United States, 45267
- Univ. of Cincinnati CRS
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Cleveland, Ohio, United States, 44106
- Case CRS
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Columbus, Ohio, United States, 43210
- The Ohio State Univ. AIDS CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Investigators
- Study Chair: Carey J
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Diseases, Parasitic
- Parasitic Diseases
- Protozoan Infections, Animal
- Parasitic Diseases, Animal
- Coccidiosis
- Protozoan Infections
- Cryptosporidiosis
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Paromomycin
Other Study ID Numbers
- ACTG 192
- 11167 (Registry Identifier: DAIDS ES Registry Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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