Synbiotics in Advanced HIV Infection

Not Applicable

Completed

• Conditions: HIV Infection Asymptomatic
• Interventions: Dietary Supplement: PMT25341; Dietary Supplement: Placebo

• Registration Number: NCT03009032
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-30
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMT25341	PMT25341	A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids
PLACEBO	Placebo	Lactose

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	From baseline through week 48
Changes in CD4+ T cell counts/uL	From baseline through week 48
Changes in CD8+ T cell counts/uL	From baseline through week 48
Changes in CD4/CD8 ratio	From baseline through week 48

Secondary Outcome Measures

Name	Time	Method
Changes in plasma hs-CRP levels	From baseline through week 48
Changes in plasma IFABP levels	From baseline through week 48
Changes in percentage of HLADR+/CD38+ T cells	From baseline through week 48
Microbiota composition: alpha-diversity	From baseline through week 48
Microbiota composition: Unifrac distances	From baseline through week 48
Microbiota composition: Canberra distances	From baseline through week 48
Changes in plasma soluble CD14 levels	From baseline through week 48
Changes in plasma lipoteichoic acid levels	From baseline through week 48
Changes in plasma kynurenine/tryptophan ratio	From baseline through week 48