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Synbiotics in Advanced HIV Infection

NCT03009032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2017-08-01

No results posted yet for this study

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.

Conditions

  • HIV Infection Asymptomatic

Interventions

DIETARY_SUPPLEMENT

PMT25341

DIETARY_SUPPLEMENT

Placebo

Lactose

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • Hospital Universitario 12 de Octubre

    collaborator OTHER

  • Hospital Universitario La Paz

    collaborator OTHER

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    collaborator OTHER

  • Hospital San Pedro de Logroño

    collaborator OTHER

  • Hospital del Mar

    collaborator OTHER

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-07-31
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009032 on ClinicalTrials.gov