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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Integrase strand transfer inhibitors

• Registration Number: NCT04460924
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-08
• Study Start: 2020-11-01
• Status Verified: 2022-03
• Primary Completion: 2022-12-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MSM HIV-infected on ART with <350 CD4 Tcells	Integrase strand transfer inhibitors	Men who have sex with men with HIV infection, on ART and with \<350 CD4 T cells/uL
MSM HIV negative patients starting PEP with INST	Integrase strand transfer inhibitors	Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir
MSM HIV-infected starting ART	Integrase strand transfer inhibitors	Men who have sex with men with HIV infection, starting ART
MSM HIV-infected on ART with >500 CD4 Tcells	Integrase strand transfer inhibitors	Men who have sex with men with HIV infection, on ART and with \>500 CD4 T cells/uL

Primary Outcome Measures

Name	Time	Method
Beta diversity changes of fecal microbiota composition	Baseline and 1 month, 3 months, 12 months	Beta diversity changes of fecal microbiota composition between study groups
Alpha diversity changes of fecal microbiota composition	Baseline and 1 month, 3 months, 12 months	Alpha diversity changes of fecal microbiota composition between study groups

Trial Locations

Locations (1)

Hospital Ramón y Cajal and Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain