Synbiotics in Advanced HIV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infection Asymptomatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PMT25341

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

Group Type EXPERIMENTAL

PMT25341

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

Lactose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Lactose

Interventions

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PMT25341

Intervention Type DIETARY_SUPPLEMENT

Placebo

Lactose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No