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

NCT04460924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-09-13

No results posted yet for this study

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

DRUG

Integrase strand transfer inhibitors

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

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-12-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460924 on ClinicalTrials.gov