NCT03009032|Completed
Synbiotics in Advanced HIV Infection
PROMALTIA
Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
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PROMALTIA
Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
Sponsor study identifier
interventional
77
0 countries
N/A
Study Start
February 2014
Actual (reported)Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Actual (reported)December 28, 2016
Actual (reported)January 4, 2017
Actual (reported)July 2017
Actual (reported)July 2017
Actual (reported)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
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 hs-CRP levels
From baseline through week 48
A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids
Lactose
Lactose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
77 participants (actual enrollment reported by the registry).
First Submitted
December 28, 2016
First Posted
January 4, 2017
Study Start
February 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
August 1, 2017
Record last verified: 2017-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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