HIV PositiveBIGGERNCT03660722
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
A study testing blood and urinary samples in people with HIV Positive, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- HIV Positive
- What is being tested?
- blood and urinary samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
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.
- Conditions
- HIV Positive
- Being tested
- blood and urinary samples
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urinary samplesOther
blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Blood and urinary sample | Other | Blood and urinary sample in HIV 1 positive adults initiating treatment Receives: Other: blood and urinary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
faecal microbial alpha-diversity
Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .
Measured: At 12 weeks
Secondary outcomes (5)
markers of gut epithelium integrity
Change in markers of gut epithelium integrity and bacterial translocation
Measured: At 12 weeks
inflammatory marker
Change in inflammatory marker (c-reactive protein)
Measured: at 12 weeks
circulating markers of monocyte activation
Change in circulating marker of monocyte activation
Measured: at 12 weeks
renal glomerular biomarkers
Change in renal glomerular biomarker (KIM-1)
Measured: at 12 weeks
bone biomarkers
Change in bone biomarkers
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startOct 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine GAGNEUX-BRUNON, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660722
- Sponsor's protocol ID
- 1708212
- Other IDs
- 2018-001358-84, 2018
- Acronym
- BIGGER
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
- ClinicalTrials.gov ID
- NCT03660722
- Acronym / sponsor ID
- BIGGER / 1708212
- Conditions
- HIV Positive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood and urinary sample | Other | Other: blood and urinary samplesBlood and urinary sample in HIV 1 positive adults initiating treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and urinary samplesblood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks | Other | Blood and urinary sample |
Primary outcome
faecal microbial alpha-diversity
Time frame: At 12 weeks
Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .
5 secondary outcomes
markers of gut epithelium integrity
Time frame: At 12 weeks
inflammatory marker
Time frame: at 12 weeks
circulating markers of monocyte activation
Time frame: at 12 weeks
renal glomerular biomarkers
Time frame: at 12 weeks
bone biomarkers
Time frame: at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine GAGNEUX-BRUNON, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and urinary samples in people with HIV Positive, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
faecal microbial alpha-diversity (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.