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Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation.
None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause.
In this longitudinal study we aim:
Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | HIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics | Dietary Supplement | probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium) |
| Measure | Description | Time Frame |
|---|---|---|
| Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+) | Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+ | Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1) | 3 months |
| CD4 recovery (ΔCD4) | CD4 recovery (ΔCD4),in blood at T0 and T1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Vullo, MD | University of Rome "Sapienza" (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy | Rome | RM | 00161 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26376436 | Derived | d'Ettorre G, Ceccarelli G, Giustini N, Serafino S, Calantone N, De Girolamo G, Bianchi L, Bellelli V, Ascoli-Bartoli T, Marcellini S, Turriziani O, Brenchley JM, Vullo V. Probiotics Reduce Inflammation in Antiretroviral Treated, HIV-Infected Individuals: Results of the "Probio-HIV" Clinical Trial. PLoS One. 2015 Sep 16;10(9):e0137200. doi: 10.1371/journal.pone.0137200. eCollection 2015. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| 3 months |
| Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy) |
| Rome |
| 00161 |
| Italy |
| D019602 |
| Food and Beverages |