Synbiotics in Advanced HIV Infection (PROMALTIA)

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: HIV Infection Asymptomatic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: PMT25341

Study type: Interventional

Funder types: Other

Identifiers

NCT03009032

14/016

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups, including a placebo group

PMT25341

Experimental group

Description:

A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids

Treatment:

Dietary Supplement: PMT25341

PLACEBO

Placebo Comparator group

Description:

Lactose

Treatment:

Dietary Supplement: Placebo