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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02164344
Acronym
PROBIO-HIV
Enrollment
30
Registered
2014-06-16
Start date
2013-01-31
Completion date
2014-07-31
Last updated
2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Gut, probiotics, immune activation

Brief summary

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: 1. to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics. 2. 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.

Interventions

DIETARY_SUPPLEMENTprobiotics

probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)3 monthsDelta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)

Secondary

MeasureTime frameDescription
Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+3 monthsDelta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)
CD4 recovery (ΔCD4)3 monthsCD4 recovery (ΔCD4),in blood at T0 and T1

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026