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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

Primary Purpose

Cryptosporidiosis, HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paromomycin sulfate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptosporidiosis focused on measuring Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Paromomycin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • USC CRS
  • Univ. of Miami AIDS CRS
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Weiss Memorial Hosp.
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Methodist Hosp. of Indiana
  • Washington U CRS
  • SUNY - Buffalo, Erie County Medical Ctr.
  • NY Univ. HIV/AIDS CRS
  • Cornell University A2201
  • Univ. of Cincinnati CRS
  • Case CRS
  • The Ohio State Univ. AIDS CRS
  • Puerto Rico-AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000771
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptosporidiosis, HIV Infections
Keywords
Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Paromomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
68 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paromomycin sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carey J
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Weiss Memorial Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell University A2201
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
11049793
Citation
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. doi: 10.1086/318155. Epub 2000 Oct 25.
Results Reference
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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

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