A Double Blind, Randomized, Placebo-Controlled Phase Ii Study to Assess The Safety and Efficacy of Orally Administered Sp-303 for The Symptomatic Treatment of Diarrhea in Patients With AIDS
| Autor: | Mark Holodniy, Jamey M Schmidt, James E Pennington, Mark Mistal, Steven B. Porter, Atul Khandwala, Johannes Koch |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
Adult
Diarrhea Male medicine.medical_specialty Anti-HIV Agents medicine.medical_treatment Administration Oral Phases of clinical research Placebo Antiviral Agents Catechin law.invention Placebos Feces Biopolymers Double-Blind Method Randomized controlled trial law Oral administration Internal medicine Humans Medicine Antidiarrheals Acquired Immunodeficiency Syndrome Chemotherapy Hepatology business.industry Gastroenterology Crofelemer HIV Protease Inhibitors Middle Aged Surgery Clinical trial Female Safety medicine.symptom business Follow-Up Studies |
| Zdroj: | American Journal of Gastroenterology. 94:3267-3273 |
| ISSN: | 0002-9270 |
| DOI: | 10.1111/j.1572-0241.1999.01535.x |
| Popis: | The aim of this study was to investigate the safety and effectiveness of orally administered SP-303 in patients with AIDS and diarrhea.This is a multicenter, phase II, randomized, double blind, placebo-controlled study. HIV-positive subjects with a history of a CD4 count200 or an AIDS-defining illness were admitted to an inpatient study unit and screened for diarrhea defined as at least three abnormal (i.e., soft or watery) stools and200 g of abnormal stool weight over a 24-h period. Subjects discontinued all antidiarrheal agents24 h before enrollment. Stool samples were studied for routine pathogens. Subjects received 500 mg p.o. of SP-303 or placebo every 6 h for 96 h (4 days). Stool frequency and weights were recorded. Subjects were monitored for symptoms and side effects and were seen 1 wk later in follow-up.A total of 26 subjects received SP-303, and 25 received placebo. There were no significant demographic differences between treatment arms. A total of 41 subjects (80%) were receiving antiretroviral therapy and 39 subjects (77%) were receiving at least one protease inhibitor. Stool studies revealed no pathogens in 48 of 51 patients (94%). There were no serious adverse events or laboratory abnormalities. The SP-303 treatment group demonstrated a mean reduction from baseline stool weight of 451 g/24 h versus 150 g/24 h with placebo on day 4 of treatment (p = 0.14), and a mean reduction in abnormal stool frequency of three abnormal stools in 24 h versus two in 24 h in the placebo group (p = 0.30). Daily measures analysis over 4 days of treatment demonstrated that SP-303 subjects had a significant reduction in stool weight (p = 0.008) and abnormal stool frequency (p = 0.04) when compared to placebo-treated subjects.SP-303 is safe and well tolerated. These results suggest that SP-303 may be effective in reducing stool weight and frequency in patients with AIDS and diarrhea. |
| Databáze: | OpenAIRE |
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