Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy

Study Overview
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Brief Summary
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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: to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics. to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status 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.

Official Title
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Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy and Non-virological Study of the Effects of Therapy

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV positive patients HIV viral load < 50 copies/ml antiretroviral therapy from at least 2 years Exclusion Criteria: intestinal diseases opportunistic diseases pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>HIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months | Dietary Supplement: probiotics<br>* probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Gut, probiotics, immune activation