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.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000771
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Estimated Enrollment: 68
Study Completion Date: September 1996
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000771

Locations
United States, California
USC CRS
Los Angeles, California, United States
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
Weiss Memorial Hosp.
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States, 46202
United States, Missouri
Washington U CRS
St. Louis, Missouri, United States
United States, New York
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Cornell University A2201
New York, New York, United States, 10021
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 45267
Case CRS
Cleveland, Ohio, United States, 44106
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210
Puerto Rico
Puerto Rico-AIDS CRS
San Juan, Puerto Rico
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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000771     History of Changes
Other Study ID Numbers: ACTG 192, 11167
Study First Received: November 2, 1999
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections, Animal
Parasitic Diseases, Animal
Coccidiosis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paromomycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 30, 2014