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

NCT04460924 | Completed FDA Drug

• 1 other identifier: ARTiBIOME: Observational study
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

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

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

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

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

Interventions

Integrase strand transfer inhibitors DRUG

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

MSM HIV negative patients starting PEP with INST; MSM HIV-infected on ART with <350 CD4 Tcells; MSM HIV-infected on ART with >500 CD4 Tcells; MSM HIV-infected starting ART

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Willing to sign consent form
• Men with an age \>18 years
• Engagement in insertive or receptive anal intercourse with another men

You may not qualify if:

• Previous history of ART exposure
• Use of antibiotics in the past 3 months
• Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Ramón y Cajal and Hospital Clínico San Carlos

Madrid, 28034, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)