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
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cryptosporidiosis; HIV Infections
Intervention: Paromomycin sulfate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Carey J, Study Chair
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.
Clinical Details
Official title: 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
Study design: Treatment, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Univ of Puerto Rico, San Juan 009365067, Puerto Rico
Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Louis A Weiss Memorial Hosp, Chicago, Illinois 60640, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana 46202, United States
SUNY / State Univ of New York, Syracuse, New York 13210, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States
Cornell Univ Med Ctr, New York, New York 10021, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States
Columbia Presbyterian Med Ctr, New York, New York 100323784, United States
Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York 10467, United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp, Bronx, New York 10461, United States
Case Western Reserve Univ, Cleveland, Ohio 44106, United States
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Additional Information
Related publications: 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.
Last updated: June 23, 2005
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