Clinical trial
ARTiBIOME: Effect of HIV and ART on Gut Microbiome
Name
ARTiBIOME: Observational study
Description
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.
Trial arms
Trial start
2020-11-01
Estimated PCD
2022-12-01
Trial end
2023-03-01
Status
Completed
Treatment
Integrase strand transfer inhibitors
Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
Arms:
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
Size
120
Primary endpoint
Alpha diversity changes of fecal microbiota composition
Baseline and 1 month, 3 months, 12 months
Beta diversity changes of fecal microbiota composition
Baseline and 1 month, 3 months, 12 months
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Feces'}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-09-13
1 organization
1 product
1 indication
Indication
HIV Infections