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| Name | Class |
|---|---|
| Hospital San Carlos, Madrid | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
| Hospital Universitario La Paz | OTHER |
| Instituto de Investigación Sanitaria de la Fundación JimĆ©nez DĆaz |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMT25341 | Experimental | A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids |
|
| PLACEBO | Placebo Comparator | Lactose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMT25341 | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition: alpha-diversity | From baseline through week 48 | |
| Microbiota composition: Unifrac distances | From baseline through week 48 | |
| Microbiota composition: Canberra distances |
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Inclusion Criteria:
Exclusion Criteria:
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| OTHER |
| Hospital San Pedro de LogroƱo | OTHER |
| Hospital del Mar | OTHER |
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Lactose |
|
| 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 |
| Changes in plasma IFABP levels | From baseline through week 48 |
| Changes in plasma lipoteichoic acid levels | 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 |