NCT04460924

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

ARTiBIOME: Effect of HIV and ART on Gut Microbiome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Integrase strand transfer inhibitors	Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2020-07-08
• Last updated: 2023-09-13

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study