Clinical trial NCT02164344: Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV
Gut
probiotics
immune activation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
timeFrame: 3 months
Secondary outcomes:
measure: Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+
timeFrame: 3 months
measure: CD4 recovery (ΔCD4)
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
state: RM
city: Rome
country: Italy
facility: Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy)
Study officials:
affiliation: University of Rome "Sapienza" (Italy)
name: Vincenzo Vullo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.