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Home > "A" Clinical Trials Conditions > A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-positive Patients with Intestinal Microsporidiosis  A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-positive Patients with Intestinal Microsporidiosis
A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-positive Patients with Intestinal Microsporidiosis
For Condition: Protozoan Infections,HIV Infections
Status: Completed
Sponsor(s): SmithKline Beecham ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Saint Luke's Hosp / Services and Research 1301
New York City, New York, 10025
United States
New York Univ
New York City, New York, 10016
United States
George Washington Univ 5-403A
Washington D.C., District of Columbia, 20037
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Deaconess Hosp / Harvard Med School / Infect Disease
Boston, Massachusetts, 02215
United States
San Francisco Gen Hosp / Div of GI
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: 274A; SK 62979/029,GHBA 659
Study Start Date:
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002191
Other Hiv Infections Studies:
1. A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC
2. A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
3. The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
4. A Study of Amprenavir in HIV-Infected Patients
5. Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
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A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-positive Patients with Intestinal Microsporidiosis
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