Clinical trial NCT03009032: Synbiotics in Advanced HIV Infection
Official title: Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection Asymptomatic
Keywords: HIV
immunologic recovery
microbiota
prebiotics
probiotics
synbiotics
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Hospital San Carlos, Madrid
name: Hospital Universitario 12 de Octubre
name: Hospital Universitario La Paz
name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Hospital San Pedro de Logroño
name: Hospital del Mar
First posted: 2017-01-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From baseline through week 48
measure: Changes in CD4+ T cell counts/uL
timeFrame: From baseline through week 48
measure: Changes in CD8+ T cell counts/uL
timeFrame: From baseline through week 48
measure: Changes in CD4/CD8 ratio
timeFrame: From baseline through week 48
Secondary outcomes:
measure: Microbiota composition: alpha-diversity
timeFrame: From baseline through week 48
measure: Microbiota composition: Unifrac distances
timeFrame: From baseline through week 48
measure: Microbiota composition: Canberra distances
timeFrame: From baseline through week 48
measure: Changes in plasma soluble CD14 levels
timeFrame: From baseline through week 48
measure: Changes in plasma hs-CRP levels
timeFrame: From baseline through week 48
measure: Changes in plasma IFABP levels
timeFrame: From baseline through week 48
measure: Changes in plasma lipoteichoic acid levels
timeFrame: From baseline through week 48
measure: Changes in plasma kynurenine/tryptophan ratio
timeFrame: From baseline through week 48
measure: Changes in percentage of HLADR+/CD38+ T cells
timeFrame: From baseline through week 48
Other outcomes:
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