Synbiotics in Advanced HIV Infection (PROMALTIA)

July 30, 2017 updated by: Sergio Serrano-Villar, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PMT25341
A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids
Dietary supplement: PMT25341
PLACEBO_COMPARATOR: PLACEBO
Lactose
Dietary supplement: Placebo
Lactose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Hospital del Mar
Hospital Universitario 12 de Octubre
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital San Carlos, Madrid
Hospital Universitario La Paz
Hospital San Pedro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2014

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (ESTIMATE)

January 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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