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

HIV Infections Clinical Trial

Official title:

ARTiBIOME: Effect of HIV and ART on Gut Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460924
• Other study ID #: ARTiBIOME: Observational study
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2022
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal and Hospital Clínico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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