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.
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.
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 group | Role | What they receive |
|---|---|---|
| non comparative | Bariatric 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.
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
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
Measure of steatotest to assess the liver steatosis
Measured: 30 months
Measure of serum inflammatory biomarkers assessed by ELISA assay
Measured: 30 months
Measure of viral load in plasma and adipose tissue assessed by quantification using Cobas 6800 system/cobas HIV-1 Test (Roche)
Measured: 30 months
Measure of the pharmacokinetics of antiretrovirals by estimating trough plasma concentrations using mass spectrometry assay.
Measured: 30 months
Measure of the pharmacokinetics of antiretrovirals by estimating trough adipose tissue concentrations using mass spectrometry assay.
Measured: 30 months
Secondary outcomes (7)
Measure of left ventricular mass assessed by echocardiography to evaluate cardiovascular function
Measured: 30 months
Measure of Volume of epicardial fat assessed by echocardiography to evaluate cardiovascular function
Measured: 30 months
Carotid intima media thickness assessed by echo-doppler to evaluate cardiovascular atherosclerosis
Measured: 30 months
Score of calcification assessed by cardiac CT to evaluate cardiovascular atherosclerosis
Measured: 30 months
Measure of body composition assessed by dexascan to evaluate the impact of sleeve gastrectomy
Measured: 30 months
Measure of the surface of the adipose tissue subcutaneous and visceral assessed by tomodensitometry to evaluate the impact of sleeve gastrectomy
Measured: 30 months
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.
- First posted30 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2022
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie POURCHER MARTINEZ, MD, PhD, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port
- ClinicalTrials.gov ID
- NCT02820337
- Acronym / sponsor ID
- ObéVIH / CREPATS 05
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 30 Jun 2016 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non comparative | – | –Bariatric surgery patients infected with HIV, overweight with controlled viral load and HIV lipohypertrophy particularly truncal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Uncontrolled severe infection
- Current pregnancy (positive HCG)
- Saving justice, guardianship
- Participation to another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Measure of steatotest to assess the liver steatosis
Time frame: 30 months
Measure of serum inflammatory biomarkers assessed by ELISA assay
Time frame: 30 months
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
Measure of the pharmacokinetics of antiretrovirals by estimating trough plasma concentrations using mass spectrometry assay.
Time frame: 30 months
Measure of the pharmacokinetics of antiretrovirals by estimating trough adipose tissue concentrations using mass spectrometry assay.
Time frame: 30 months
7 secondary outcomes
Measure of left ventricular mass assessed by echocardiography to evaluate cardiovascular function
Time frame: 30 months
Measure of Volume of epicardial fat assessed by echocardiography to evaluate cardiovascular function
Time frame: 30 months
Carotid intima media thickness assessed by echo-doppler to evaluate cardiovascular atherosclerosis
Time frame: 30 months
Score of calcification assessed by cardiac CT to evaluate cardiovascular atherosclerosis
Time frame: 30 months
Measure of body composition assessed by dexascan to evaluate the impact of sleeve gastrectomy
Time frame: 30 months
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
Measure of bone mineral density assessed by dexascan to evaluate the impact of sleeve gastrectomy
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- 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.
Valérie POURCHER MARTINEZ, MD, PhD principal investigator
Groupe Hospitalier Pitie-Salpetriere
1 site in 1 country: see every site and its status.
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.