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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Integrase strand transfer inhibitors

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04460924

ARTiBIOME: Observational study

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

120 participants in 5 patient groups

MSM HIV-uninfected and ART naïve

Description:

Men who have sex with men without HIV infection, not receiving ART

MSM HIV-infected starting ART

Description:

Men who have sex with men with HIV infection, starting ART

Treatment:

Drug: Integrase strand transfer inhibitors

MSM HIV-infected on ART with >500 CD4 Tcells

Description:

Men who have sex with men with HIV infection, on ART and with \>500 CD4 T cells/uL

Treatment:

Drug: Integrase strand transfer inhibitors

MSM HIV-infected on ART with <350 CD4 Tcells

Description:

Men who have sex with men with HIV infection, on ART and with \<350 CD4 T cells/uL

Treatment:

Drug: Integrase strand transfer inhibitors

MSM HIV negative patients starting PEP with INST

Description:

Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir

Treatment:

Drug: Integrase strand transfer inhibitors