HIV Infections
Conditions
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.
Interventions
Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
Sponsors
Merck Sharp & Dohme LLC
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alpha diversity changes of fecal microbiota composition | 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 | Baseline and 1 month, 3 months, 12 months | Beta diversity changes of fecal microbiota composition between study groups |
Countries
Spain
Outcome results
None listed