Synbiotics in Advanced HIV Infection
Synbiotics in Advanced HIV Infection
NCT ID: NCT03009032 Phase: NA Status: COMPLETED Enrollment: 77 Completion: 2017-07
Conditions
HIV Infection Asymptomatic
Interventions
PMT25341, Placebo
Summary
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.
Primary Outcome
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0