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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000771
Other study ID # ACTG 192
Secondary ID 11167
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date September 1996

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date September 1996
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Paromomycin sulfate


Locations

Country Name City State
Puerto Rico Puerto Rico-AIDS CRS San Juan
United States SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York
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 Univ. of Cincinnati CRS Cincinnati Ohio
United States Case CRS Cleveland Ohio
United States The Ohio State Univ. AIDS CRS Columbus Ohio
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States Methodist Hosp. of Indiana Indianapolis Indiana
United States USC CRS Los Angeles California
United States Univ. of Miami AIDS CRS Miami Florida
United States Cornell University A2201 New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States Washington U CRS Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

Hewitt RG, Yiannoutsos CT, Carey J, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat J, Fass RJ, Higgs ES, Antoninjevic Z, Walawander AL, Flanigan T, Bender J. A double-blind, placebo-controlled trial of paromomycin (par) for the treatment of cryptosporidiosis (cs) in patients with advanced HIV disease and CD4 counts under 150 (ACTG 192). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 4)

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. Epub 2000 Oct 25. — View Citation

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