ARTiBIOME: Observational Study on the Effect of HIV and ART on Gut Microbiome

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal120 enrolled

Overview

Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. However, little is known on the impact of the antiretroviral treatment on this population and very few studies have evaluated these alterations. The aim of this study is to study microbiome on healthy patients and HIV-infected patients exposed to antiretroviral treatment with integrase strand transfer inhibitors.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

HIV Infections

Interventions

Integrase strand transfer inhibitorsDRUG

Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion criteria: * Willing to sign consent form * Men with an age \>18 years * Engagement in insertive or receptive anal intercourse with another men \*Exclusion criteria: * Previous history of ART exposure * Use of antibiotics in the past 3 months * Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.

Outcomes

Primary Outcomes

Alpha diversity changes of fecal microbiota composition

Alpha diversity changes of fecal microbiota composition between study groups

Time frame: Baseline and 1 month, 3 months, 12 months

Beta diversity changes of fecal microbiota composition

Beta diversity changes of fecal microbiota composition between study groups