NCT03009032

Synbiotics in Advanced HIV Infection

Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PMT25341
DIETARY_SUPPLEMENT	Placebo	Lactose

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-01-04
• Last updated: 2017-08-01