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

NCT ID: NCT04460924

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-03-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MSM HIV-uninfected and ART naïve

Men who have sex with men without HIV infection, not receiving ART

No interventions assigned to this group

MSM HIV-infected starting ART

Men who have sex with men with HIV infection, starting ART

Integrase strand transfer inhibitors

Intervention Type: DRUG

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

Integrase strand transfer inhibitors

Intervention Type: DRUG

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

Integrase strand transfer inhibitors

Intervention Type: DRUG

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

Integrase strand transfer inhibitors

Intervention Type: DRUG

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

Interventions

Integrase strand transfer inhibitors

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Ramón y Cajal and Hospital Clínico San Carlos

Madrid, , Spain

Countries

Spain

Other Identifiers

ARTiBIOME: Observational study

Identifier Type: -

Identifier Source: org_study_id