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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
SmithKline Beecham


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002191

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1997
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Protozoan Infections
HIV Infections

Drug : Albendazole
Phase 3

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

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: NCT00002191

Locations

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

Sponsors and Collaborators

SmithKline Beecham
More Information

More Information


Responsible Party: SmithKline Beecham  
ClinicalTrials.gov Identifier: NCT00002191   History of Changes  
Other Study ID Numbers: 274A  
  SK 62979/029  
  GHBA 659  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Placebos
Protozoan Infections
Intestinal Diseases
Albendazole
Microsporida
Anthelmintics

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Protozoan Infections
Microsporidiosis
Albendazole

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.