NCT00000771

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

September 1, 1996

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

CryptosporidiosisHIV Infections

Keywords

CryptosporidiosisAcquired Immunodeficiency SyndromeParomomycin

Interventions

Paromomycin sulfateDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

USC CRS

Los Angeles, California, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Weiss Memorial Hosp.

Chicago, Illinois, 60640, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp. of Indiana

Indianapolis, Indiana, 46202, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Cornell University A2201

New York, New York, 10021, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Puerto Rico-AIDS CRS

San Juan, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 11049793BACKGROUND

MeSH Terms

Conditions

CryptosporidiosisHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Carey J

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

September 1, 1996

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(14)PR(1)