NCT02820337Completed
Pathophysiological Study of Adipose Tissue of Patients Infected With HIV
ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port
Source: ClinicalTrials.gov · Last updated 2 Feb 2024
Brief summary (registry, in English)
The main goal of our project is the study of subcutaneous and visceral (SAT and VAT) adipose tissue taken during bariatric surgery (Single port sleeve gastrectomy) of subjects with HIV infection, anf morbid obesity with undetectable viral load (VL) and having HIV lipohypertrophy particularly truncal. The study covers both the morphology of adipocytes,fibrosis, immune activation and inflammation, gene expression, pharmacology of antiretroviral drugs (ARV) and the measurement of viral replication in the adipose tissue and the plasma before and after bariatric surgery.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 20 (actual)
- First submitted
- 29 Apr 2016
- Start date
- 1 Jul 2016
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- NCT number
- NCT02820337
What you commit to
- Study type: Observational
- Participants enrolled: 20
- From 1 Jul 2016 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled severe infection
Other
- Current pregnancy (positive HCG)
- Saving justice, guardianship
- Participation to another study.
Who the study is looking for
- Documented HIV-1 infection,
- Aged to 18 at 65 ans,
- Obesity defined as a Body Mass Index (BMI)\> 35 kg / M² with comorbidities Or BMI \> 40 kg/M²
- Forget bariatric surgery after a positive opinion of the specialized multidisciplinary meeting
- on stable antiretroviral therapy for 12 months
- with controlled HIV infection (\<50 copies / ml)
- Signed informed consent
- Karnofsky Index \> 80 %
- Patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yasmine Dudoit Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.