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

Study Overview
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Brief Summary
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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.

Official Title
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ARTiBIOME: Effect of HIV and ART on Gut Microbiome

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Integrase strand transfer inhibitors


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MSM HIV-uninfected and ART naïve<br>Men who have sex with men without HIV infection, not receiving ART | |
| MSM HIV-infected starting ART<br>Men who have sex with men with HIV infection, starting ART | Drug: Integrase strand transfer inhibitors<br>* Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment<br>|
| MSM HIV-infected on ART with >500 CD4 Tcells<br>Men who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL | Drug: Integrase strand transfer inhibitors<br>* Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment<br>|
| MSM HIV-infected on ART with <350 CD4 Tcells<br>Men who have sex with men with HIV infection, on ART and with <350 CD4 T cells/uL | Drug: Integrase strand transfer inhibitors<br>* Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment<br>|
| MSM HIV negative patients starting PEP with INST<br>Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir | Drug: Integrase strand transfer inhibitors<br>* Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha diversity changes of fecal microbiota composition | Alpha diversity changes of fecal microbiota composition between study groups | 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 | Baseline and 1 month, 3 months, 12 months |