Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects (NCT03660722) | Clinical Trial Compass
WithdrawnNot Applicable
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
Stopped: study not started
France0Started 2023-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
faecal microbial alpha-diversity
Timeframe: At 12 weeks
Trial details
NCT IDNCT03660722
SponsorCentre Hospitalier Universitaire de Saint Etienne