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Sponsored by: |
SmithKline Beecham |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002191 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Hypersensitivity to albendazole.
Prior Medication:
Excluded:
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 |
Study ID Numbers: | 274A, SK 62979/029, GHBA 659 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002191 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Placebos Protozoan Infections Intestinal Diseases |
Albendazole Microsporida Anthelmintics |
Opportunistic Infections Protozoan Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Intestinal Diseases Immunologic Deficiency Syndromes Albendazole Virus Diseases |
Mycoses HIV Seropositivity HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Parasitic Diseases Retroviridae Infections Microsporidiosis |
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Antiplatyhelmintic Agents Mitosis Modulators |
Anthelmintics Antimitotic Agents Infection Pharmacologic Actions Anticestodal Agents Antiparasitic Agents Therapeutic Uses Tubulin Modulators Lentivirus Infections |