HIV Infection Asymptomatic
Conditions
Keywords
HIV, immunologic recovery, microbiota, prebiotics, probiotics, synbiotics
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.
Interventions
DIETARY_SUPPLEMENTPMT25341
DIETARY_SUPPLEMENTPlacebo
Lactose
Sponsors
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
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Changes in plasma hs-CRP levels | From baseline through week 48 |
| Changes in plasma IFABP levels | From baseline through week 48 |
| Microbiota composition: alpha-diversity | From baseline through week 48 |
| Changes in plasma kynurenine/tryptophan ratio | From baseline through week 48 |
| Changes in percentage of HLADR+/CD38+ T cells | From baseline through week 48 |
| Changes in plasma lipoteichoic acid levels | 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 |
Outcome results
None listed