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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital Ramón y Cajal and Hospital Clínico San Carlos

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrase strand transfer inhibitors

Drug

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

Primary outcomes

Alpha diversity changes of fecal microbiota composition

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

Alpha diversity changes of fecal microbiota composition between study groups
Beta diversity changes of fecal microbiota composition

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

Beta diversity changes of fecal microbiota composition between study groups

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

ARTiBIOME: Effect of HIV and ART on Gut Microbiome

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Jul 8, 2020
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed