Synbiotics in Advanced HIV Infection

NCT03009032 | Completed

• 1 other identifier: 14/016
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infection Asymptomatic

Keywords

HIV; immunologic recovery; microbiota; prebiotics; probiotics; synbiotics

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• 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

Study Arms (2)

PMT25341

EXPERIMENTAL

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

Dietary Supplement: PMT25341

PLACEBO

PLACEBO COMPARATOR

Lactose

Dietary Supplement: Placebo

Interventions

PMT25341 DIETARY_SUPPLEMENT

PMT25341

Placebo DIETARY_SUPPLEMENT

Lactose

PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Pregnancy
• Type 1 or 2 diabetes
• End-stage renal disease
• Lactose intolerance
• Use of immunomodulatory drugs
• Neutrophil count \<750cells/uL

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Hospital San Carlos, Madrid: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital Universitario La Paz: collaborator
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator
• Hospital San Pedro de Logroño: collaborator
• Hospital del Mar: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: February 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share