Trial record 1 of 41 for:    " March 02, 2011":" April 01, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Proliant Health & Biologicals
Information provided by (Responsible Party):
David Asmuth, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01313910
First received: March 10, 2011
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel movements and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms. The study will also examine the effect of ImmunoLin® on the bacteria in the gut and the immune system in gut tissue as well as in the blood.


Condition Intervention
HIV
Dietary Supplement: Immunolin®

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • frequency of GI-related symptoms after an 8-week treatment course [ Time Frame: 8 weeks (56 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency of pro-inflammatory bacterial orders [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    stool sample, duodenal aspirate, and duodenal biopsy tissue

  • measures of gut permeability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    by the five-hour disaccharide absorption test and serum levels of bacteria antigens

  • inflammation [ Time Frame: days 20, 40 & 56 ] [ Designated as safety issue: Yes ]
    including CD8+ T-cells with an activated phenotype, stool calprotectin, and plasma/tissue pro-inflammatory cytokines and including LPS and D-dimer

  • CD3+/CD4+ and CD3+/CD8+ population frequencies [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    duodenal tissue


Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ImmunoLin®
8-week treatment course
Dietary Supplement: Immunolin®
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GI complaints consisting of at least 2 loose or watery stools per day or marked abdominal bloating that adversely effects activities of daily living (ADLs) or common social functioning for greater than 6 months, even though the symptomatology may wax and wane over that time period.
  • Subjects should have had routine testing to exclude enteric pathogens.
  • Subjects should have made an effort to identify food intolerance, especially lactose intolerance.
  • Symptoms should be believed to be independent of ART or other medications known to have the potential to cause similar GI complaints; either because the symptoms predate initiation of the medications or shifts between different options for ART has had no appreciable effect on symptoms.
  • Over the previous 6 months, alcohol use should be characterized as occasional with less than 1.5 ounces per day being the maximum estimated use (<2 beers or glasses of wine or 1 drink of hard liquor).
  • Subjects will be greater than 18 years of age.
  • Plasma HIV load should be suppressed to less than 400 cp/mL for at least four months, but there is no restriction on peripheral CD4+ T-cell count. Blips of <1000 cp/mL are allowed, provided that these are not associated with medication interruptions and that the pVL is undetectable before and after the observed blip.
  • Subjects are willing to maintain a food and GI-symptom diary while receiving the ImmunoLin® supplement.
  • Subjects should be willing to attempt to maintain a stable regimen of ART for the duration of the study unless indicated for patient safety.
  • Subjects should be free of antibiotic use for at least 3-weeks prior to study entry except for chronic antibiotics used for prophylaxis according to SOC in HIV management. Usage of antibiotics during the course of the study will be assessed on a case by case basis by the study team.
  • Subjects must be free of conditions which require chronic therapy that are known to alter the gut flora. Steroid use must be limited to intermittent topical preparations only which includes inhaled or dermatologic routes of application.

Exclusion Criteria:

  • known unrelated causes for GI abnormalities.
  • abnormal coagulation parameters (PT>1.2 ULN)
  • thrombocytopenia (platelet count <50,000 within 6 weeks)
  • contra-indications to upper endoscopy or conscious sedation
  • anemia (> grade 1 [appendix D])
  • aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
  • positive pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313910

Locations
United States, California
UCD CTSC Clinical Research Center (CCRC)
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Proliant Health & Biologicals
Investigators
Principal Investigator: David M. Asmuth, MD University of California, Davis Int Med: ID
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Asmuth, MD, Professor/ Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT01313910     History of Changes
Other Study ID Numbers: 225193 (201118675)
Study First Received: March 10, 2011
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
HIV
diarrhea

Additional relevant MeSH terms:
HIV Enteropathy
HIV Infections
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Intestinal Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014