Synbiotics in Advanced HIV Infection

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

HIV Infection Asymptomatic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-infected ART-naive subjects with \<350 CD4 T cells/mm3 or AIDS * Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines Exclusion Criteria: * Age \<18 years * Pregnancy * Type 1 or 2 diabetes * End-stage renal disease * Lactose intolerance * Use of immunomodulatory drugs * Neutrophil count \<750cells/uL

Outcomes

Primary Outcomes

Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0