Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients with chronic idiopathic diarrhea

David Asmuth, John E. Hinkle, Anthony LaMarca, Carl J. Fichtenbaum, Ma Somsouk, Netanya S. Utay, Audrey L. Shaw, Bryon W. Petschow, Christopher J. Detzel, Eric M. Weaver

Research output: Contribution to journalArticle

Abstract

Objectives: To evaluate serum-derived bovine immunoglobulin/protein isolate (SBI) for safety and impact on gastrointestinal (GI) symptoms in HIV patients with chronic idiopathic diarrhea. Methods: A multi-center trial comprised of a double-blind, placebo (PBO)-controlled lead-in phase, (participants received PBO or SBI at 2.5 or 5.0 g BID for 4 weeks) followed by a 20-week, PBO-free phase (SBI at either 2.5 or 5.0 g BID). Participants included HIV-infected patients who were virologically suppressed with a history of chronic idiopathic diarrhea, defined as > 3 loose stools per day for ≥ 3 months without an identifiable cause. Safety was evaluated by monitoring adverse events (AEs) and clinical laboratory testing. Health status and changes in GI symptoms were assessed using validated questionnaires. Results: SBI was well tolerated by the 103 participants with only 2 withdrawals due to AEs potentially associated with SBI. Mean number of daily unformed stools decreased from about 4 at baseline to less than 2 by week 4 for all study groups. Improvements in several other GI symptoms were also reported. Comparison of the PBO group to SBI groups showed no significant differences, although both SBI cohorts reported significantly improved health status scores. GI symptom improvements were maintained throughout the 20-week PBO-free phase. Conclusions: Oral SBI is safe and well tolerated at the doses studied in HIV patients with chronic diarrhea. No conclusions could be drawn regarding impact on GI symptoms. Additional studies are ongoing to examine the biological and immunologic effects of SBI in virologically suppressed HIV-infected patients.

Original languageEnglish (US)
Pages (from-to)205-213
Number of pages9
JournalHIV Clinical Trials
Volume18
Issue number5-6
DOIs
StatePublished - Nov 2 2017

Keywords

  • Bovine immunoglobulins
  • Chronic diarrhea
  • HIV-associated enteropathy
  • Safety evaluation

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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