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Visbiome Extra Strength · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Visbiome Extra Strength | ACTIVE_COMPARATOR | - |
| Placebo for Visbiome Extra Strength | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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...
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Visbiome Extra Strength is an investigational small molecule being studied for its effects on the gut microbiome and immune activation markers in people with HIV-1 Infection. It is a probiotic product being evaluated in a Phase 2 clinical trial to assess its potential impact on these markers in the context of HIV-1 infection.
Visbiome Extra Strength is a probiotic that targets the gut microbiome. The Phase 2 trial NCT02706717 is designed to evaluate its effects on the gut microbiome and immune activation markers in individuals with HIV-1 Infection. The study aims to understand how modifying the microbiome may influence immune activation in this patient population.
Visbiome Extra Strength is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research on this probiotic product for its potential role in HIV-1 Infection, specifically focusing on gut microbiome and immune activation markers.
Visbiome Extra Strength is in Phase 2 clinical development. It is an investigational product, not yet approved by regulatory authorities. The Phase 2 trial has been completed, with results expected to inform further development. It is being studied for its effects on gut microbiome and immune activation in HIV-1 Infection.
Visbiome Extra Strength has one completed Phase 2 clinical trial, NCT02706717, titled 'Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome & Immune Activation Markers'. This randomized, double-blind, placebo-controlled study enrolled 93 participants with HIV-1 Infection across the United States and Puerto Rico, with a minimum age of 18 years.
Visbiome Extra Strength is a specific formulation of the probiotic product Visbiome, distinguished by its 'Extra Strength' designation. While both are probiotic products, Visbiome Extra Strength is the subject of a dedicated Phase 2 clinical trial (NCT02706717) evaluating its effects on gut microbiome and immune activation markers in HIV-1 Infection.