A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Protozoan Infections; HIV Infections
Intervention: Albendazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: SmithKline Beecham
Summary
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.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
Study design: Treatment, Double-Blind, Safety Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Davies Med Ctr, San Francisco, California 94114, United States
San Francisco Gen Hosp / Div of GI, San Francisco, California 94110, United States
George Washington Univ 5-403A, Washington, District of Columbia 20037, United States
Deaconess Hosp / Harvard Med School / Infect Disease, Boston, Massachusetts 02215, United States
New York Univ, New York, New York 10016, United States
Saint Luke's Hosp / Services and Research 1301, New York, New York 10025, United States
Additional Information
Last updated: June 23, 2005
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