Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with \<350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.
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Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: From baseline through week 48
Changes in CD4+ T cell counts/uL
Timeframe: From baseline through week 48
Changes in CD8+ T cell counts/uL
Timeframe: From baseline through week 48
Changes in CD4/CD8 ratio
Timeframe: From baseline through week 48