Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects (BIGGER)

Centre Hospitalier Universitaire de Saint Etienne

Status

Withdrawn

Conditions

HIV Positive

Treatments

Other: blood and urinary samples

Study type

Interventional

Funder types

Other

Identifiers

NCT03660722

1708212

2018-001358-84 (EudraCT Number)

Details and patient eligibility

About

Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-1 positive
Age 18-64 years
Able to give informed consent
Not previously treated for chronic HIV-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
Due to commence antiretroviral therapy by treating clinician

Exclusion criteria

- Previous major intestinal surgery/inflammatory bowel conditions
Infective diarrhoea in the last 3 months
BMI<18.5
Currently pregnant OR planning to conceive during the study period
Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months