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Pathophysiological Study of Adipose Tissue of Patients Infected With HIV (ObéVIH)

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ClinicalTrials.gov Identifier: NCT02820337
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

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.

Condition or disease
HIV

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
non comparative
Bariatric surgery patients infected with HIV, overweight with controlled viral load and HIV lipohypertrophy particularly truncal



Primary Outcome Measures :
  1. Measure of fibrotest to assess the liver fibrosis [ Time Frame: 30 months ]
    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.

  2. Measure of actitest to assess the liver inflammation [ Time Frame: 30 months ]
    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.

  3. Measure of steatotest to assess the liver steatosis [ Time Frame: 30 months ]
  4. Measure of serum inflammatory biomarkers assessed by ELISA assay [ Time Frame: 30 months ]
  5. Measure of viral load in plasma and adipose tissue assessed by quantification using Cobas 6800 system/cobas HIV-1 Test (Roche) [ Time Frame: 30 months ]
  6. Measure of the pharmacokinetics of antiretrovirals by estimating trough plasma concentrations using mass spectrometry assay. [ Time Frame: 30 months ]
  7. Measure of the pharmacokinetics of antiretrovirals by estimating trough adipose tissue concentrations using mass spectrometry assay. [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. Measure of left ventricular mass assessed by echocardiography to evaluate cardiovascular function [ Time Frame: 30 months ]
  2. Measure of Volume of epicardial fat assessed by echocardiography to evaluate cardiovascular function [ Time Frame: 30 months ]
  3. Carotid intima media thickness assessed by echo-doppler to evaluate cardiovascular atherosclerosis [ Time Frame: 30 months ]
  4. Score of calcification assessed by cardiac CT to evaluate cardiovascular atherosclerosis [ Time Frame: 30 months ]
  5. Measure of body composition assessed by dexascan to evaluate the impact of sleeve gastrectomy [ Time Frame: 30 months ]
  6. Measure of the surface of the adipose tissue subcutaneous and visceral assessed by tomodensitometry to evaluate the impact of sleeve gastrectomy [ Time Frame: 30 months ]
  7. Measure of bone mineral density assessed by dexascan to evaluate the impact of sleeve gastrectomy [ Time Frame: 30 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820337


Contacts
Contact: Yasmine Dudoit 330142164181 yasmine.dudoit@aphp.fr

Locations
France
Yasmine Dudoit Recruiting
Paris, France, 75013
Contact: Yasmine Dudoit    330142164181    yasmine.dudoit@aphp.fr   
Contact: Valérie Pourcher-Martinez, MD, PhD    330142164184    valerie.martinez@aphp.fr   
Sponsors and Collaborators
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Investigators
Principal Investigator: Valérie POURCHER MARTINEZ, MD, PhD Groupe Hospitalier Pitié-Salpêtrière

Responsible Party: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier: NCT02820337     History of Changes
Other Study ID Numbers: CREPATS 05
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No