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Synbiotics in Advanced HIV Infection (PROMALTIA)

Primary Purpose

HIV Infection Asymptomatic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PMT25341
Placebo
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection Asymptomatic focused on measuring HIV, immunologic recovery, microbiota, prebiotics, probiotics, synbiotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PMT25341

    PLACEBO

    Arm Description

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

    Lactose

    Outcomes

    Primary Outcome Measures

    Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Changes in CD4+ T cell counts/uL
    Changes in CD8+ T cell counts/uL
    Changes in CD4/CD8 ratio

    Secondary Outcome Measures

    Microbiota composition: alpha-diversity
    Microbiota composition: Unifrac distances
    Microbiota composition: Canberra distances
    Changes in plasma soluble CD14 levels
    Changes in plasma hs-CRP levels
    Changes in plasma IFABP levels
    Changes in plasma lipoteichoic acid levels
    Changes in plasma kynurenine/tryptophan ratio
    Changes in percentage of HLADR+/CD38+ T cells

    Full Information

    First Posted
    December 28, 2016
    Last Updated
    July 30, 2017
    Sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
    Collaborators
    Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital San Pedro de Logroño, Hospital del Mar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03009032
    Brief Title
    Synbiotics in Advanced HIV Infection
    Acronym
    PROMALTIA
    Official Title
    Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
    Collaborators
    Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital San Pedro de Logroño, Hospital del Mar

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection Asymptomatic
    Keywords
    HIV, immunologic recovery, microbiota, prebiotics, probiotics, synbiotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PMT25341
    Arm Type
    Experimental
    Arm Description
    A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids
    Arm Title
    PLACEBO
    Arm Type
    Placebo Comparator
    Arm Description
    Lactose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PMT25341
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Lactose
    Primary Outcome Measure Information:
    Title
    Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Time Frame
    From baseline through week 48
    Title
    Changes in CD4+ T cell counts/uL
    Time Frame
    From baseline through week 48
    Title
    Changes in CD8+ T cell counts/uL
    Time Frame
    From baseline through week 48
    Title
    Changes in CD4/CD8 ratio
    Time Frame
    From baseline through week 48
    Secondary Outcome Measure Information:
    Title
    Microbiota composition: alpha-diversity
    Time Frame
    From baseline through week 48
    Title
    Microbiota composition: Unifrac distances
    Time Frame
    From baseline through week 48
    Title
    Microbiota composition: Canberra distances
    Time Frame
    From baseline through week 48
    Title
    Changes in plasma soluble CD14 levels
    Time Frame
    From baseline through week 48
    Title
    Changes in plasma hs-CRP levels
    Time Frame
    From baseline through week 48
    Title
    Changes in plasma IFABP levels
    Time Frame
    From baseline through week 48
    Title
    Changes in plasma lipoteichoic acid levels
    Time Frame
    From baseline through week 48
    Title
    Changes in plasma kynurenine/tryptophan ratio
    Time Frame
    From baseline through week 48
    Title
    Changes in percentage of HLADR+/CD38+ T cells
    Time Frame
    From baseline through week 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Synbiotics in Advanced HIV Infection

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