A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
This study has been completed.
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by:
NIH AIDS Clinical Trials Information Service
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.
Primary Purpose: Treatment
||A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
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.
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|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002191
|San Francisco Gen Hosp / Div of GI
|San Francisco, California, United States, 94110 |
|Davies Med Ctr
|San Francisco, California, United States, 94114 |
|George Washington Univ 5-403A
|Washington, District of Columbia, United States, 20037 |
|Deaconess Hosp / Harvard Med School / Infect Disease
|Boston, Massachusetts, United States, 02215 |
|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 |
History of Changes
|Other Study ID Numbers:
||November 2, 1999
||August 31, 2001
|Last Update Posted:
||June 24, 2005
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Molecular Mechanisms of Pharmacological Action