AzTrials
AzTrials

HIV-1 InfectionPhase 2NCT02706717

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

A Phase 2 study testing Visbiome Extra Strength in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
Visbiome Extra Strength
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
25 sitesin 2 countries
Study dates
Apr 2016to 28 Aug 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 27Show fewer
  • 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
  • Aspartate aminotransferase (AST) (SGOT) ≤5 x upper limit normal (ULN)
  • Alanine aminotransferase (ALT) (SGPT) ≤5 x ULN
  • Alkaline phosphatase ≤5 x upper limit normal ULN
  • Total bilirubin ≤2.5 x ULN (if on atazanavir ≤5 x ULN)
  • Calculated creatinine clearance (CrCl) >60 mL/min, as estimated by the Cockcroft-Gault equation.
  • For females of reproductive potential, negative serum or urine pregnancy test within 45 days prior to entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point-of-care (POC)/ CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
  • If participating in sexual activity that could lead to pregnancy, the female study participant must be willing to use a contraceptive while receiving protocol-specified medication. At least one of the following methods MUST be used:
  • Condoms (male or female), with or without a spermicidal agent
  • Diaphragm or cervical cap with spermicide
  • Intrauterine device (IUD)
  • Hormone-based contraceptive
  • Ability and willingness of participant or legal guardian/representative to provide informed consent.

Who cannot join

  • 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.
  • NOTE: Antibiotics for opportunistic infection prophylaxis are exclusionary.
  • 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.
Show all 29Show fewer
  • 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.
  • Use of any of the following medications/products for more than 3 consecutive days within the 60 days prior to study entry:
  • Immunosuppressives (eg, azathioprine, corticosteroids greater than 20 mg per day [physiologic replacement doses are allowed], cyclosporine, mycophenolate, intravenous immunoglobulin (IVIG), interferon, sirolimus, sulfasalazine, tacrolimus).
  • Immune modulators (eg, cytokines [eg, IL-2], granulocyte colony stimulating factor, growth hormone, tumor necrosis factor antagonists, thalidomide).
  • Antineoplastic agents (except for topical agents for skin cancer).
  • Probiotics and prebiotics (supplements and products).
  • NOTE: Yogurt with live cultures is allowed.
  • History of lactose intolerance or milk allergy.
  • Any episode of acute or persistent diarrhea within 60 days prior to study entry.
  • NOTES:
  • Diarrhea is defined as three or more stools per day that are liquid/loose/watery and will take the shape of a container. If the duration of loose stools meeting this criterion definition is greater than 30 days, this is chronic diarrhea and is not exclusionary.
  • Acute diarrhea is defined as 3-14 day duration.
  • Persistent diarrhea is defined as 15-30 day duration.
  • Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

United States24 sites

  • University of Colorado Hospital CRS (6101)

    Aurora, Colorado, 80045

  • Johns Hopkins Adult AIDS CRS (201)

    Baltimore, Maryland, 21287

  • 31788 Alabama CRS

    Birmingham, Alabama, 35294

  • Unc Aids Crs (3201)

    Chapel Hill, North Carolina, 27514

  • Northwestern University CRS (2701)

    Chicago, Illinois, 60611

  • Rush University Medical Center (2702)

    Chicago, Illinois, 60612

  • University of Cincinnati CRS (2401)

    Cincinnati, Ohio, 45267

  • Case CRS (2501)

    Cleveland, Ohio, 44106

  • The Ohio State University AIDS CRS (2301)

    Columbus, Ohio, 43210

  • Trinity Health and Wellness Center CRS (31443)

    Dallas, Texas, 75208

  • Greensboro CRS (3203)

    Greensboro, North Carolina, 27401

  • Houston AIDS Research Team CRS (31473)

    Houston, Texas, 77030

  • UCLA CARE Center CRS (601)

    Los Angeles, California, 90095

  • Vanderbilt Therapeutics CRS (3652)

    Nashville, Tennessee, 37204

  • 7804 Weill Cornell Chelsea CRS

    New York, New York, 10010

  • Columbia Physicians and Surgeons CRS (30329)

    New York, New York, 10032

  • 7803 Weill Cornell Upton CRS

    New York, New York, 10065

  • 31786 New Jersey Medical School Clinical Research Center CRS

    Newark, New Jersey, 07103

  • 6201 Penn Therapeutics CRS

    Philadelphia, Pennsylvania, 19104

  • Pittsburgh CRS (1001)

    Pittsburgh, Pennsylvania, 15213

  • 701 University of California, San Diego AntiViral Research Center CRS

    San Diego, California, 92103

  • 801 University of California, San Francisco HIV/AIDS CRS

    San Francisco, California, 94110

  • University of Washington AIDS CRS (1401)

    Seattle, Washington, 98104

  • Washington University CRS (2101)

    St Louis, Missouri, 63110

Other trials in United States

Puerto Rico1 site

  • Puerto Rico-AIDS CRS (5401)

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: Safety, Tolerability, and Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome and Immune Activation Markers in HIV-Infected Participants on Suppressive Antiretroviral Therapy: A Phase II Study

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.

Read the detailed description

This was a phase II, randomized, double-blind, two-arm study to evaluate whether there is a significant change in sCD14 after 24 weeks of probiotic Visbiome Extra Strength (ES) therapy, and to determine the safety and tolerability of this agent in HIV-infected participants on stable antiretroviral therapy (ART). Participants were randomized 1:1 to Visbiome ES and placebo arms. Both arms initiated study treatment at Week 2 and took 1 sachet per day for the first 2 weeks and then 1 sachet twice daily for the next 22 weeks. All participants were followed for an additional 12 weeks off study product.

The study clinic visits included Entry (Week 0), and Weeks 2, 6, 14, 25, 26, and 38. Plasma for the primary outcome was collected at Weeks 0, 2, 25, and 26. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, and laboratory tests) were done at Weeks 2, 6, 14, 26, and 38.

Currently, the results are entered for the primary outcome measure and select secondary outcomes only. The results on the remaining secondary outcomes will be posted when they become available.

Conditions
HIV-1 Infection
Being tested
Visbiome Extra Strength, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visbiome Extra StrengthDrug

    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.

  • PlaceboDrug

    Also called Control

    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.

Study groups in NCT02706717
Study groupRoleWhat they receive
Visbiome Extra StrengthActive comparatorNot described
Receives: Drug: Visbiome Extra Strength
Placebo for Visbiome Extra StrengthPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Weeks 0, 2, 25, and 26

Secondary outcomes (29)

  1. Change in IL-6 From Week 2 to Week 26

    IL-6 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

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

    All values were log10 transformed prior to calculating change and conducting analyses.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change.

    Measured: Weeks 2 and 26

  3. Change in sCD163 From Week 2 to Week 26

    sCD163 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  4. Change in sTNF-RI From Week 2 to Week 26

    sTNF-RI data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  5. Change in Oxidized LDL From Week 2 to Week 26

    Oxidized LDL data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  6. Change in Kynurenine to Tryptophan Ratio From Week 2 to Week 26

    Fold change was calculated as the value at Week 26 divided by the value at Week 2.

    Measured: Weeks 2 and 26

  7. Change in D-dimer From Week 2 to Week 26

    All values were log10 transformed prior to calculating change and conducting analyses.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change.

    Measured: Weeks 2 and 26

  8. Change in LPS From Week 2 to Week 26

    LPS data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  9. Change in LBP From Week 2 to Week 26

    LBP data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  10. Change in CD4+ Cell Count From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  11. Change in CD4+/CD8+ Ratio From Week 2 to Week 26.

    Fold change was calculated as the value at Week 26 divided by the value at Week 2.

    Measured: Weeks 2 and 26

  12. Change in %CD14++CD16- From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  13. Change in %CD14++CD16+ From Week 2 to Week 26

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  14. Change in %CD14lowCD16hi From Week 2 to Week 26

    %CD14lowCD16hi data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  15. Change in %CD4+CD38+ From Week 2 to Week 26.

    %CD4+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  16. Change in %CD4+HLA-DR+ From Week 2 to Week 26.

    %CD4+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  17. Change in %CD4+CD38+HLA-DR+ From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  18. Change in %CD8+CD38+ From Week 2 to Week 26.

    %CD8+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  19. Change in %CD8+HLA-DR+ From Week 2 to Week 26.

    %CD8+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.

    Measured: Weeks 2 and 26

  20. Change in %CD8+CD38+HLA-DR+ From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  21. Change in %CD4+CD28-CD57+ From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  22. Change in %CD8+CD28-CD57+ From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  23. Change in Chao1 Richness Index From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Chao1 is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Chao reference). Chao1 diversity is a richness measure which quantifies how many different types there are in a given dataset. The Chao 1 index can range from 1 to infinity as it is constrained only by the number of types defined as measurable. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered.

    Measured: Weeks 2 and 26

  24. Change in Shannon Diversity Index From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Shannon is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Lemos and Magurran references). The Shannon index is an estimator of richness and evenness. It quantifies uncertainty (entropy) within a dataset. The Shannon Index ranges from 0-5. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered.

    Measured: Weeks 2 and 26

  25. Change in Chao1 Richness Index From Week 26 to Week 38.

    Absolute change was calculated as the value at Week 38 minus the value at Week 26.

    Chao1 is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Chao reference). Chao1 diversity is a richness measure which quantifies how many different types there are in a given dataset. The Chao 1 index can range from 1 to infinity as it is constrained only by the number of types defined as measurable. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered.

    Measured: Weeks 26 and 38

  26. Change in Shannon Diversity Index From Week 26 to Week 38.

    Absolute change was calculated as the value at Week 38 minus the value at Week 26.

    Shannon is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Lemos and Magurran references). The Shannon index is an estimator of richness and evenness. It quantifies uncertainty (entropy) within a dataset. The Shannon Index ranges from 0-5. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the "types" that are considered.

    Measured: Weeks 26 and 38

  27. Change in I-FABP From Week 2 to Week 26.

    Absolute change was calculated as the value at Week 26 minus the value at Week 2.

    Measured: Weeks 2 and 26

  28. Safety

    Summary of the highest adverse event grade (0-5) for each participant.

    Protocol definition of Adverse Events: 1) signs and symptoms Grade ≥3 and any that led to a change in treatment regardless of grade; 2) new diagnoses; 3) Grade ≥3 lab values and any that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade.

    DAIDS AE Grading Table, Version 2.0 was used.

    Measured: Treatment dispensation to Week 38

  29. Tolerability

    Tolerability was successfully completing the protocol-defined treatment period.

    Measured: Treatment dispensation to Week 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion5 Jun 2017
  4. Study completion28 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706717
Sponsor's protocol ID
ACTG A5350
Other IDs
1U01AI068636
Status last verified
Dec 2019
First submitted
8 Mar 2016
Last updated
6 Jan 2020
Data monitoring committee
Yes

Publications

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

  • 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.

    PubMed 21457733

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Visbiome Extra Strength in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sCD14 From Baseline to Week 25/26 (time frame: Weeks 0, 2, 25, and 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706717, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in