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HIVObéVIHNCT02820337

Pathophysiological Study of Adipose Tissue of Patients Infected With HIV

An observational study of HIV, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV
How many people
20 participants
Where
1 siteFrance
Study dates
Jul 2016to 15 Dec 2023
Phase
Observational
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
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  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Yasmine Dudoit

    Paris, 75013

Other trials in France

About this study

Official title: ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port

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.

Read the detailed description

The choice of the sleeve gastrectomy is based on choosing an effective technique with few complications, no rupture of digestive continuity and therefore little malabsorptive effect with a better quality of life.

The intervention of sleeve gastrectomy offers a unique opportunity to study the SAT and VAT of HIV obese patients before and after bariatric surgery, to analyze the specific modifications of this tissue and to better understand the pathophysiology of this disease. The term associated with changes in cardiometabolic comorbidities and their improvement after weight loss will be important elements in the management of these patients. It is therefore important to evaluate whether the fibrosis term changes observed in HIV patients will change the effectiveness of the intervention.

In the general population, obesity is a major public health problem. It is considered an inflammatory disease, multifactorial with chronic evolution, which requires long-term medical care and / or surgery . Indeed, the body mass index (BMI) correlates with increased mortality mainly due to cardiovascular diseases (hypertension, coronary artery disease), cancer and diabetes. Finally, overweight and obesity are the leading causes of liver disease in Western countries resulting in nonalcoholic fatty liver disease, a term that includes all the hepatic lesions observed in overweight and obesity: steatosis, steatohepatitis, fibrosis, cirrhosis or hepatocellular carcinoma. Nonalcoholic fatty liver disease reflects not only the presence of insulin resistance but also participates in its installation. Reducing overweight is therefore a key part of treatment to reduce chronic inflammation, insulin resistance and liver damage.

There is little data in the literature on the prevalence of obesity in the population of HIV patients. In France, the prevalence of obesity in the French Hospital Database on HIV is 15.1% among women and 5.3% among men, similar to prevalence in the general population. Patients born in sub-Saharan Africa have a higher risk with 20.7% versus 12.2% in women and 10.9% versus 4.7% for men.

No data is available on the obesity complications described in the general population in our population of obese HIV patients. Nevertheless, apart from obesity, patients infected with HIV develop cardiovascular and metabolic complications well documented in recent years.

French and international recommendations agree that the management of obesity should be multidisciplinary. In the treatment, surgical treatment is the treatment of choice in French and international recommendations in the following indications:

  • morbid obesity (BMI ≥ 40 kg / M²) resistant to medical treatment and exposing patients to serious complications that can not be controlled by the specific treatment
  • obesity with BMI between 35 and 40 kg / M² with comorbidities associated with life-threatening or functional outcomes: cardiovascular disease, musculoskeletal disease, severe metabolic disorders not controlled by maximal medical therapy. In each case, the indication can be considered in patients who have had access to specialized medical care for at least 6 months, also including complementary approaches (diet, physical activity, management of psychological problems, treatment complications).

At present, the sleeve gastrectomy is the technique of choice in the general population with, compared to other bariatric surgery techniques such as bypass, reducing complications, length of hospital stay, operative time, a gain in term quality of life without disruption of digestive continuity and therefore little or no malabsorption. This lack of malabsorption it an argument of choice in our HIV patients on cART with a reduced risk of malabsorption of ARV and vitamin deficiencies such as vitamin D deficiency already well described in HIV. The minimally invasive approach (1 trocar), routinely performed by Dr. G. Pourcher for obese patients whether they are infected with HIV, reduces surgical risk. This Single port also allows easy access to SAT, VAT and liver.

The management of obesity in the HIV population, now having a similar life expectancy should be the same as that of the general population but remains to this day very marginal. The literature on the subject is almost "poor" Additionally, comorbid conditions existing in the population of HIV patients are a target population requiring support at least equivalent to that of the general population.

Conditions
HIV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02820337
Study groupRoleWhat they receive
non comparativeBariatric surgery patients infected with HIV, overweight with controlled viral load and HIV lipohypertrophy particularly truncal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 months

  2. 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.

    Measured: 30 months

  3. Measure of steatotest to assess the liver steatosis

    Measured: 30 months

  4. Measure of serum inflammatory biomarkers assessed by ELISA assay

    Measured: 30 months

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

    Measured: 30 months

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

    Measured: 30 months

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

    Measured: 30 months

Secondary outcomes (7)
  1. Measure of left ventricular mass assessed by echocardiography to evaluate cardiovascular function

    Measured: 30 months

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

    Measured: 30 months

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

    Measured: 30 months

  4. Score of calcification assessed by cardiac CT to evaluate cardiovascular atherosclerosis

    Measured: 30 months

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

    Measured: 30 months

  6. Measure of the surface of the adipose tissue subcutaneous and visceral assessed by tomodensitometry to evaluate the impact of sleeve gastrectomy

    Measured: 30 months

  7. Measure of bone mineral density assessed by dexascan to evaluate the impact of sleeve gastrectomy

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2022
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820337
Sponsor's protocol ID
CREPATS 05
Acronym
ObéVIH
Status last verified
Feb 2024
First submitted
29 Apr 2016
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 2 Feb 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Measure of fibrotest to assess the liver fibrosis (time frame: 30 months). The study lists 7 primary outcomes in all. 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 2 Feb 2024.

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