Pathophysiological Study of Adipose Tissue of Patients Infected With HIV

NCT02820337 | Completed DMC

• 1 other identifier: CREPATS 05
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (7)

• Measure of fibrotest to assess the liver fibrosis

  fibrotest is the estimated index of liver fibrosis established according to the assay values of 5 parameters: alpha-2 macroglobulin, haptoglobin, apolipoprotein-A1, total bilirubin and g-glutamyl-transpeptidase.

  30 months

• Measure of actitest to assess the liver inflammation

  ActiTest gives an estimate of the intensity of the inflammation and liver cell killing activity. ActiTest uses 5 markers fibrotest which is added the dosage of transaminases measure of Ambulatory blood pressure.

  30 months

• Measure of steatotest to assess the liver steatosis

  30 months

• Measure of serum inflammatory biomarkers assessed by ELISA assay

  30 months

• Measure of viral load in plasma and adipose tissue assessed by quantification using Cobas 6800 system/cobas HIV-1 Test (Roche)

  30 months

• Measure of the pharmacokinetics of antiretrovirals by estimating trough plasma concentrations using mass spectrometry assay.

  30 months

• Measure of the pharmacokinetics of antiretrovirals by estimating trough adipose tissue concentrations using mass spectrometry assay.

  30 months

Secondary Outcomes (7)

• Measure of left ventricular mass assessed by echocardiography to evaluate cardiovascular function

  30 months

• Measure of Volume of epicardial fat assessed by echocardiography to evaluate cardiovascular function

  30 months

• Carotid intima media thickness assessed by echo-doppler to evaluate cardiovascular atherosclerosis

  30 months

• Score of calcification assessed by cardiac CT to evaluate cardiovascular atherosclerosis

  30 months

• Measure of body composition assessed by dexascan to evaluate the impact of sleeve gastrectomy

  30 months

Study Arms (1)

non comparative

Bariatric surgery patients infected with HIV, overweight with controlled viral load and HIV lipohypertrophy particularly truncal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pathophysiology of adipose tissue of obese HIV-infected patients undergoing a sleeve gastrectomy using single port. 20 patients will be required. Patients will be included after positive opinion of the multidisciplinary meeting of management of obesity.

You may qualify if:

• 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)

You may not qualify if:

• Uncontrolled severe infection
• Current pregnancy (positive HCG)
• Saving justice, guardianship
• Participation to another study.

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Yasmine Dudoit

Paris, 75013, France

Location

Study Officials

• Valérie POURCHER MARTINEZ, MD, PhD

  Groupe Hospitalier Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: June 30, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)