Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Oct 2023
- Ended
- Feb 2024
- Type of study
- Interventional
- Treatments tested
- blood and urinary samples
- Record updated
- 22 November 2023
- Why it stopped
- study not started
Who can take part
- Age
- 18 years to 64 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- - Previous major intestinal surgery/inflammatory bowel conditions
- Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
- Infective diarrhoea in the last 3 months
- BMI<18.5
- Currently pregnant OR planning to conceive during the study period
- Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Blood and urinary sampleOther group
Blood and urinary sample in HIV 1 positive adults initiating treatment
Treatment: blood and urinary samples
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
- Record updated
- 22 November 2023