PMID- 29210625
OWN - NLM
STAT- MEDLINE
DCOM- 20180709
LR  - 20220408
IS  - 1945-5771 (Electronic)
IS  - 1528-4336 (Linking)
VI  - 18
IP  - 5-6
DP  - 2017 Nov-Dec
TI  - Evaluation of oral serum-derived bovine immunoglobulins in HIV-infected patients 
      with chronic idiopathic diarrhea.
PG  - 205-213
LID - 10.1080/15284336.2017.1401256 [doi]
AB  - 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.
FAU - Asmuth, David M
AU  - Asmuth DM
AD  - a University of California Davis Medical Center , Sacramento , CA , USA.
FAU - Hinkle, John E
AU  - Hinkle JE
AD  - b EarlyPhase Sciences, Inc. , Cary , NC , USA.
FAU - LaMarca, Anthony
AU  - LaMarca A
AD  - c Therafirst Medical Centers , Ft. Lauderdale , FL , USA.
FAU - Fichtenbaum, Carl J
AU  - Fichtenbaum CJ
AD  - d University of Cincinnati , Cincinnati , OH , USA.
FAU - Somsouk, Ma
AU  - Somsouk M
AD  - e University of California San Francisco , San Francisco , CA , USA.
FAU - Utay, Netanya S
AU  - Utay NS
AD  - f McGovern Medical School , University of Texas , Houston , TX , USA.
FAU - Shaw, Audrey L
AU  - Shaw AL
AD  - g Entera Health, Inc. , Cary , NC , USA.
FAU - Petschow, Bryon W
AU  - Petschow BW
AUID- ORCID: 0000-0002-7431-7006
AD  - g Entera Health, Inc. , Cary , NC , USA.
FAU - Detzel, Christopher J
AU  - Detzel CJ
AD  - g Entera Health, Inc. , Cary , NC , USA.
FAU - Weaver, Eric M
AU  - Weaver EM
AD  - g Entera Health, Inc. , Cary , NC , USA.
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Immunoglobulins)
RN  - 0 (Immunologic Factors)
RN  - 0 (Placebos)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Animals
MH  - Cattle
MH  - Chronic Disease/drug therapy
MH  - Cross-Over Studies
MH  - Diarrhea/*drug therapy/pathology
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - HIV Infections/*complications
MH  - Humans
MH  - Immunoglobulins/*administration & dosage/adverse effects/isolation & purification
MH  - Immunologic Factors/*administration & dosage/adverse effects/isolation & 
      purification
MH  - Male
MH  - Middle Aged
MH  - Placebos/administration & dosage
MH  - Prospective Studies
MH  - Serum/chemistry
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bovine immunoglobulins
OT  - Chronic diarrhea
OT  - HIV-associated enteropathy
OT  - Safety evaluation
EDAT- 2017/12/07 06:00
MHDA- 2018/07/10 06:00
CRDT- 2017/12/07 06:00
PHST- 2017/12/07 06:00 [entrez]
PHST- 2017/12/07 06:00 [pubmed]
PHST- 2018/07/10 06:00 [medline]
AID - 10.1080/15284336.2017.1401256 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2017 Nov-Dec;18(5-6):205-213. doi: 
      10.1080/15284336.2017.1401256.