A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis

June 23, 2005 updated by: SmithKline Beecham
To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the double-blind portion of study, patients receive albendazole or placebo for 28 days; in the open-label portion of study, patients receive albendazole for 62 days.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp / Div of GI
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ 5-403A
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Deaconess Hosp / Harvard Med School / Infect Disease
    • New York
      • New York, New York, United States, 10016
        • New York Univ
      • New York, New York, United States, 10025
        • Saint Luke's Hosp / Services and Research 1301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Required:

  • If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks.

Allowed:

  • Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization.
  • Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization.

Patients must have:

  • HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary.
  • Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization.
  • Average of > 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume > 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE:
  • Patients receiving antidiarrheal therapy must meet these criteria despite such therapy.
  • History of an average of > 3 liquid bowel movements per day for three additional weeks immediately preceding the 7-day period described above (for a total of four weeks), as documented in the patient's chart.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Grade 4 neutropenia.
  • Decompensated liver disease.
  • Positive toxin analysis for C. difficile.
  • Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli.
  • Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter.
  • Positive fluorescent antibody test for Cryptosporidium.
  • Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization.
  • Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry.

Patients with the following prior conditions are excluded:

Hypersensitivity to albendazole.

Prior Medication:

Excluded:

  • Use of potential antiprotozoal drugs, e.g., mebendazole or metronidazole, within one week prior to enrollment.
  • Receipt of albendazole during the one month prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SmithKline Beecham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274A
  • SK 62979/029
  • GHBA 659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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