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

Inclusion Criteria

• •\- 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
• •* 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.