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

Overview

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.

Full Title of Study: “ARTiBIOME: Effect of HIV and ART on Gut Microbiome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2021

Interventions

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

Arms, Groups and Cohorts

  • MSM HIV-uninfected and ART na├»ve
    • Men who have sex with men without HIV infection, not receiving ART
  • MSM HIV-infected starting ART
    • Men who have sex with men with HIV infection, starting ART
  • MSM HIV-infected on ART with >500 CD4 Tcells
    • Men who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL
  • MSM HIV-infected on ART with <350 CD4 Tcells
    • 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
    • Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  • Collaborator
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

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