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| Sponsor: | SmithKline Beecham |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002191 |
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 III |
| 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 |
Eligibility| 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:
Contacts and 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 | |
More Information
| 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 |
|
AIDS-Related Opportunistic Infections Placebos Protozoan Infections Intestinal Diseases |
Albendazole Microsporida Anthelmintics |
|
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 Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |