Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome & Immune Activation Markers

NCT02706717 | Completed Phase 2 Results DMC

• 2 other identifiers: ACTG A53501U01AI068636
• Study Type: interventional
• Target: 93
• Locations: 2 countries
• Sites: 25

Brief Summary

The purpose of the study was to evaluate whether the probiotic Visbiome Extra Strength reduces inflammation in HIV-infected men and women when compared to a placebo (inactive medication like a dummy pill). The study evaluated whether taking Visbiome Extra Strength by mouth for 24 weeks was safe and well-tolerated for HIV-infected persons on antiretroviral therapy (ART). Probiotics are germs such as yeast or bacteria that are found in food and supplements that are used to improve the health of the digestive system. Many people refer to probiotics as "helpful bacteria." These bacteria live in the body and help the body work normally. In some medical conditions, including HIV infection, helpful bacteria are replaced with bacteria that can change the normal intestinal function and increase inflammation. The investigators tested whether giving a probiotic restored normal intestinal function and decreased inflammation.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Change in sCD14 From Baseline to Week 25/26

  Baseline is defined as the average of the Entry and Week 2 values. Week 25/26 is defined as the average of the Week 25 and Week 26 values. Absolute change was calculated as the value at Week 25/26 minus the value at Baseline.

  Weeks 0, 2, 25, and 26

Secondary Outcomes (29)

• Change in IL-6 From Week 2 to Week 26

  Weeks 2 and 26

• Change in IP-10 From Week 2 to Week 26

  Weeks 2 and 26

• Change in sCD163 From Week 2 to Week 26

  Weeks 2 and 26

• Change in sTNF-RI From Week 2 to Week 26

  Weeks 2 and 26

• Change in Oxidized LDL From Week 2 to Week 26

  Weeks 2 and 26

Study Arms (2)

Visbiome Extra Strength

ACTIVE COMPARATOR

Drug: Visbiome Extra Strength

Placebo for Visbiome Extra Strength

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Visbiome Extra Strength DRUG

From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.

Visbiome Extra Strength

Placebo DRUG

From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.

Also known as: Control

Placebo for Visbiome Extra Strength

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
• NOTE: The term "licensed" refers to a US FDA-approved kit.
• WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
• \- Currently on continuous antiretroviral therapy (ART) for ≥48 weeks prior to study entry with no change in the ART regimen within the 24 weeks prior to study entry except as noted below.
• NOTE A: Continuous ART is defined as continuous ART for the 48-week period prior to study entry with no ART interruption longer than 7 consecutive days.
• NOTE B: Modifications of ART during the 24 weeks prior to study entry are permitted in certain circumstances. For example, the change in formulation (eg, from standard formulation to fixed-dose combination including ART modifications switching from ritonavir- to cobicistat-boosted protease inhibitors or from tenofovir disoproxil fumarate to tenofovir alafenamide) is allowed within 24 weeks prior to study entry. A within-class, single-drug substitution (eg, switch from nevirapine to efavirenz or from atazanavir to darunavir) is allowed within 24 weeks prior to study entry, with the exception of a switch between any other NRTI to/from abacavir. No other changes in ART within the 24 weeks prior to study entry are permitted.
• No plan to change ART regimen for the study duration.
• Screening CD4+ cell count \>200 cells/mm3 obtained within 45 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
• Screening HIV-1 RNA levels \<50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 45 days prior to study entry.
• HIV-1 RNA levels below the limit of quantification using a FDA-approved assay with a quantification limit of 50 copies/mL or lower for at least 48 weeks prior to study entry performed by any laboratory that has a CLIA certification or its equivalent.
• NOTE: Single determinations that are between the assay quantification limit and 500 copies/mL (ie, "blips") are allowed as long as the preceding and subsequent determinations are below the level of quantification. The screening value may serve as the subsequent undetectable value following a blip.
• The following laboratory values obtained within 45 days prior to entry by any US laboratory that has a CLIA certification or its equivalent:
• Absolute neutrophil count (ANC) ≥1000/mm3
• Hemoglobin ≥10.0 g/dL for men and 9.0 g/dL for women
• Platelet count ≥50,000/mm3

You may not qualify if:

• \- Initiation of ART during acute HIV infection.
• NOTE: Participants who initiate ART within 6 months of HIV seroconversion are considered to have been initiated during acute infection and are excluded.
• \- Receipt of antibiotic therapy within 60 days prior to study entry.
• Known allergy/sensitivity or any hypersensitivity to components of Visbiome Extra Strength or its formulation.
• Use of investigational therapies or investigational vaccines within 90 days prior to study entry.
• Non-investigational vaccinations within 2 weeks prior to study entry.
• Active drug or alcohol use or dependence that in the opinion of the site investigator would interfere with adherence to study requirements.
• Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
• History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
• NOTE: Persons with positive HCV Ab but negative plasma HCV RNA are allowed to participate. Sites must document negative HCV RNA within 24 weeks of study entry.
• History of positive HBsAg within 48 weeks prior to study entry.
• Liver cirrhosis, history of inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy.
• Current diagnosis of diabetes.
• Either breastfeeding or pregnant within 24 weeks prior to study entry.
• OIs within 45 days prior to study entry.

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Exegi Pharma, LLC: collaborator

Study Sites (25)

31788 Alabama CRS

Birmingham, Alabama, 35294, United States

Location

UCLA CARE Center CRS (601)

Los Angeles, California, 90095, United States

Location

701 University of California, San Diego AntiViral Research Center CRS

San Diego, California, 92103, United States

Location

801 University of California, San Francisco HIV/AIDS CRS

San Francisco, California, 94110, United States

Location

University of Colorado Hospital CRS (6101)

Aurora, Colorado, 80045, United States

Location

Northwestern University CRS (2701)

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center (2702)

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Adult AIDS CRS (201)

Baltimore, Maryland, 21287, United States

Location

Washington University CRS (2101)

St Louis, Missouri, 63110, United States

Location

31786 New Jersey Medical School Clinical Research Center CRS

Newark, New Jersey, 07103, United States

Location

7804 Weill Cornell Chelsea CRS

New York, New York, 10010, United States

Location

Columbia Physicians and Surgeons CRS (30329)

New York, New York, 10032, United States

Location

7803 Weill Cornell Upton CRS

New York, New York, 10065, United States

Location

Unc Aids Crs (3201)

Chapel Hill, North Carolina, 27514, United States

Location

Greensboro CRS (3203)

Greensboro, North Carolina, 27401, United States

Location

University of Cincinnati CRS (2401)

Cincinnati, Ohio, 45267, United States

Location

Case CRS (2501)

Cleveland, Ohio, 44106, United States

Location

The Ohio State University AIDS CRS (2301)

Columbus, Ohio, 43210, United States

Location

6201 Penn Therapeutics CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Pittsburgh CRS (1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Therapeutics CRS (3652)

Nashville, Tennessee, 37204, United States

Location

Trinity Health and Wellness Center CRS (31443)

Dallas, Texas, 75208, United States

Location

Houston AIDS Research Team CRS (31473)

Houston, Texas, 77030, United States

Location

University of Washington AIDS CRS (1401)

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS (5401)

San Juan, 00935, Puerto Rico

Location

Related Publications (3)

• Chao, Anne. Scandinavian Journal of Statistics, 1 January 1984, Vol.11(4), pp.265-270

  BACKGROUND

• Lemos LN, Fulthorpe RR, Triplett EW, Roesch LF. Rethinking microbial diversity analysis in the high throughput sequencing era. J Microbiol Methods. 2011 Jul;86(1):42-51. doi: 10.1016/j.mimet.2011.03.014. Epub 2011 Mar 30.

  PMID: 21457733 BACKGROUND

• Magurran A. 2004. Measuring Biological Diversity. Blackwell Science Ltd, Oxford, United Kingdom

  BACKGROUND

Related Links

• The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).

Results Point of Contact

• Title: ACTG Clinicaltrials.gov Coordinator
• Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

ACTGCT.Gov@s-3.com

(301) 628-3313

Study Officials

• Adriana Andrade, MD, MPH

  Johns Hopkins University

  STUDY CHAIR

• Edgar T Overton, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2016
• Primary Completion: June 5, 2017
• Study Completion: August 28, 2017
• Last Updated: January 6, 2020
• Results First Posted: June 27, 2018

Record last verified: 2019-12

Locations

PR (1); US (24)