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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
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000771
  Purpose

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.


Condition Intervention Phase
Cryptosporidiosis
HIV Infections
Drug: Paromomycin sulfate
Phase II

MedlinePlus related topics: AIDS Cryptosporidiosis
Drug Information available for: Paromomycin Paromomycin sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 68
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000771

Locations
United States, California
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
United States, New York
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, United States, 10465
Cornell Univ Med Ctr
New York, New York, United States, 10021
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Columbia Presbyterian Med Ctr
New York, New York, United States, 100323784
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, United States, 10467
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, United States, 10461
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Investigators
Study Chair: Carey J
  More Information

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.

Study ID Numbers: ACTG 192
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000771  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Cryptosporidiosis
Acquired Immunodeficiency Syndrome
Paromomycin

Study placed in the following topic categories:
Protozoan Infections
Sexually Transmitted Diseases, Viral
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Paromomycin
Immunologic Deficiency Syndromes
Virus Diseases
Cryptosporidiosis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Parasitic Diseases
Intestinal Diseases, Parasitic
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Immune System Diseases
Coccidiosis
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Lentivirus Infections
Protozoan Infections, Animal
Parasitic Diseases, Animal
Amebicides

ClinicalTrials.gov processed this record on January 15, 2009