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

ARTiBIOME: Effect of HIV and ART on Gut Microbiome

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Integrase strand transfer inhibitors

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal and Hospital Clínico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

We will compare 20 MSM HIV negative patients starting PEP with INSTI with:

• 20 MSM HIV-uninfected and ART naïve (A)
• 20 MSM HIV-infected starting ART (B)
• 20 MSM HIV-infected on ART with >500 CD4 Tcells ( C )
• 20 MSM HIV-infected on ART with <350 CD4 Tcells (D) (the study population has been restricted to MSM given the strong influence of sexual orientation on the microbiota composition

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MSM HIV-uninfected and ART naïve; 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	Drug: Integrase strand transfer inhibitors; Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
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	Drug: Integrase strand transfer inhibitors; Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
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	Drug: Integrase strand transfer inhibitors; Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
MSM HIV negative patients starting PEP with INST; Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir	Drug: Integrase strand transfer inhibitors; Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Integrase Inhibitors
• Other Study ID Numbers: ARTiBIOME: Observational study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No