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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002191
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997
  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: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
Davies Med Ctr
San Francisco, California, United States, 94114
San Francisco Gen Hosp / Div of GI
San Francisco, California, United States, 94110
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Protozoan Infections
Microsporidiosis
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
Parasitic Diseases
Mycoses
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014