Human Immunodeficiency VirusAIACNCT04439448
Adipose Tissue and Immune Activation in HIV
An observational study of Human Immunodeficiency Virus and Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The prevalence of HIV-associated wasting declined dramatically with the introduction of effective antiretroviral therapy (ART), but as patients survive longer on treatment the proportion of overweight (body mass index [BMI] >25 kg/m2) and obese (BMI >30 kg/m2) HIV-infected individuals has been rising over time and is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Obesity
- What is being tested?
- dual-energy X-ray absorptiometry (DEXA) scan, Carotid and branchial artery ultrasound and 2-hour oral glucose tolerace test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2013to 15 Feb 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health persons with HIV receiving care at the Vanderbilt Comprehensive Care Clinic and healthy persons without HIV receiving care at Vanderbilt University Medical Center
Who may be able to join
- age >18 years
- on ART >2 years
- a CD4+ nadir >100 cells/µl prior to starting ART
- a CD4 >350 cells/µl at the time of enrollment
- HIV-1 viral load <50 copies/ml
- Pre-menopausal
Show all 9Show fewer
- age >18 years
- body mass index >= 30 kg/m2
- Pre-menopausal
Who cannot join
- Pregnant (women only)
- Current use of anti-diabetic medications or statins
- HIV uninfected participants:
- Pregnant (women only)
- Current use of anti-diabetic medications or statins
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: An Observational Cohort Study of Adipose Tissue and Immune Activation in Treated HIV Infection
The prevalence of HIV-associated wasting declined dramatically with the introduction of effective antiretroviral therapy (ART), but as patients survive longer on treatment the proportion of overweight (body mass index [BMI] >25 kg/m2) and obese (BMI >30 kg/m2) HIV-infected individuals has been rising over time and is reaching parity with the general population. Adipose tissue has broad effects on immune function relevant to HIV infection, including the basal inflammatory state and peripheral lymphocyte populations, but there are few data on the effects of high adiposity on HIV immunology. This issue is directly relevant to promoting the long-term health of ART-treated individuals, many of which can now survive for decades on treatment, as emerging evidence suggests that increased immune activation is a major risk factor for the development of cardiovascular and metabolic diseases in this population. HIV-infected individuals on ART have an approximately 2-fold higher risk of myocardial infarction and a 4-fold higher risk of type 2 diabetes mellitus, and the proportion of deaths among HIV-infected individuals due to non-AIDS conditions now exceeds those due to AIDS.
Despite the increasing proportion of overweight and obese HIV-infected persons, few prior studies have investigated the interaction between adipose tissue, immune activation, and risk factors for cardiovascular and metabolic disease in treated HIV. The overall goal of this study is to understand the complex relationships between adipose tissue, innate and cellular immune activation, and metabolic and cardiovascular disease risk factors in persons on long-term antiretroviral therapy. To this end, we will use an observational, cross-sectional cohort design to compare in vivo markers of immune activation, ex vivo cytokine expression, and metabolic and cardiovascular disease markers in HIV-infected individuals with a range of body composition profiles and between overweight/obese HIV-infected and uninfected individuals.
Read the detailed description
HIV-infected individuals on long-term ART treatment are at increased risk for many diseases, particularly diabetes mellitus and coronary artery disease, which are more commonly associated with obesity and a sedentary lifestyle. As HIV patients are now living longer on effective treatment, a growing proportion are becoming overweight and obese, and the management of non-AIDS chronic diseases associated is emerging as a major challenge to clinicians and the health care system. Excess adiposity (i.e., being overweight or obese) and treated HIV infection are associated with strikingly similar alterations in inflammatory biomarkers and cellular immune function implicated in the pathogenesis of chronic diseases, but there are few data at present on whether the effects of obesity and treated HIV are synergistic or additive. In this study we will closely investigate the effects of adipose tissue on both the innate and cellular arms of the immune system, and the relationships between adiposity, immune function, and risk factors for metabolic and cardiovascular diseases.
Heightened, chronic systemic inflammation is an important contributor to non-AIDS related morbidity and mortality among patients on ART, and treated HIV and obesity may promote increased metabolic and cardiovascular disease through similar mechanisms. Elevated serum highly-sensitive C-reactive protein (hsCRP; a more sensitive serum CRP assay used to measure inflammation), interleukin-6 (IL-6), and other innate immune-derived inflammatory markers are independently associated with increased risk of cardiovascular events, insulin resistance, and all-cause death among HIV-infected individuals. The etiology of this HIV-associated inflammation is not fully understood and likely multifactorial, but serum hsCRP and several proinflammatory cytokines (e.g., IL-6, TNF-α receptor 1) correlate with fat mass in HIV-infected adults, suggesting adipose tissue may have a role in modulating the inflammatory response.
In addition to greater inflammation, abdominal obesity is associated with altered T cell function, characterized by increased circulating markers of cellular immune activation (e.g., sCD25 and neopterin), and adipose tissue biopsies from obese individuals and animal models contain higher numbers of resident macrophages, T cells (particularly CD8+ cells) and reduced T-regulatory cells. Furthermore, adipokines (hormones produced by adipocytes), demonstrate a range of lymphocyte effects. Leptin, in particular, enhances expression of T cell activation markers after PHA stimulation, polarizes naïve CD4+ T cell proliferation towards the Th1 phenotype, and promotes Th1 cytokine production. These in vitro data are consistent with obesity modulating T cell activation, at least in part through adipokine effects.
The goal of this study is to understand the complex relationships between adipose tissue, innate and cellular immune activation, and metabolic and cardiovascular disease risk factors in persons on long-term antiretroviral therapy. Using the facilities and resources of the Vanderbilt Clinical Research Center, we will enroll an observational cohort to investigate the interactions of innate immune activation, metabolic and cardiovascular risk factors, and T cell activation among HIV-infected and uninfected adults with a range of body composition profiles from low adiposity (lean) to high adiposity (obese). The study groups will be comprised of 70 HIV-infected adults on ART with a range of body composition profiles from low adiposity (lean) to high adiposity (obese), and a control group of 30 overweight and obese uninfected individuals.
Hypothesis 1: Increased adipose tissue promotes increased innate and cellular immune activation in HIV-infected individuals on long-term ART.
Specific Aim 1a: To study the hypothesis that adipose tissue promotes innate immune activation in treated HIV by determining if serum leptin (a marker of adiposity) is positively associated with interleukin-6 (IL-6) levels, in addition to other inflammation biomarkers (including C-reactive protein), in HIV-infected persons on long-term ART with a range of body composition profiles from low adiposity (lean) to high adiposity (obese).
Specific Aim 1b: To study the hypothesis that adipose tissue promotes cellular immune activation in treated HIV by determining if serum leptin is positively associated with the percentage of CD8+ T cells expressing CD38 and HLA-DR activation markers in HIV-infected persons on long-term ART.
Hypothesis 2: Overweight and obese HIV-infected individuals on long-term ART have significantly greater markers of innate and cellular immune activation compared to uninfected individuals with equivalent adiposity.
Specific Aim 2a: To determine if IL-6 serum levels, and other inflammation biomarkers, are significantly higher among overweight/obese HIV-infected persons compared to uninfected controls with equivalent adiposity.
Specific Aim 2b: To determine if the percentage of CD38+ and HLA-DR+ CD8+ T cells is significantly higher among overweight/obese HIV-infected persons compared to uninfected controls with equivalent adiposity.
- Conditions
- Human Immunodeficiency Virus, Obesity
- Being tested
- dual-energy X-ray absorptiometry (DEXA) scan, Carotid and branchial artery ultrasound, 2-hour oral glucose tolerace test, Blood collection
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-energy X-ray absorptiometry (DEXA) scanRadiation
Whole body dual-energy X-ray absorptiometry (DEXA) scan to assess lean and fat mass
Carotid and branchial artery ultrasoundOther
Ultrasound to assess carotid plaque and brachial artery flow mediated dilation
2-hour oral glucose tolerace testDiagnostic test
Ingestion of 75g of glucose syrup with blood collection for glucose and insulin at time 0, 90min and 120min
Blood collectionDiagnostic test
Blood collection for measurement of circulating proteins (cytokines) and isolation of immune cells
| Study group | Role | What they receive |
|---|---|---|
| HIV+ non-obese | HIV+ adults on antiretroviral therapy with a body mass index <30 kg/m2 Receives: Radiation: dual-energy X-ray absorptiometry (DEXA) scan; Other: Carotid and branchial artery ultrasound; Diagnostic Test: 2-hour oral glucose tolerace test; Diagnostic Test: Blood collection | |
| HIV+ obese | HIV+ adults on antiretroviral therapy with a body mass index >=30 kg/m2 Receives: Radiation: dual-energy X-ray absorptiometry (DEXA) scan; Other: Carotid and branchial artery ultrasound; Diagnostic Test: 2-hour oral glucose tolerace test; Diagnostic Test: Blood collection | |
| HIV-negative obese | HIV-negative adults on antiretroviral therapy with a body mass index >=30 kg/m2 Receives: Radiation: dual-energy X-ray absorptiometry (DEXA) scan; Other: Carotid and branchial artery ultrasound; Diagnostic Test: 2-hour oral glucose tolerace test; Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD38+ CD4+ T cells
Flow cytometry measurement of CD38 expression on isolated CD4+ T cells
Measured: At study enrollment
Plasma interleukin-6
Level of circulating interleukin-6
Measured: At study enrollment
Secondary outcomes (3)
Carotid intima media thickness
Ultrasound measurement of carotid intima media thickness
Measured: At study enrollment
Brachial artery maximal flow mediated dilation
Ultrasound measurement of maximal brachial artery dilation after 5 minutes of hypoxia
Measured: At study enrollment
Visceral adipose tissue volume (cm3)
Dual-energy x-ray assessment of visceral adipose tissue volume
Measured: At study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start12 Apr 2013
- Primary completion3 Nov 2014
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Koethe, Vanderbilt University Medical Center
- Investigators
- John Koethe, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439448
- Sponsor's protocol ID
- K23AI100700
- Acronym
- AIAC
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at this time to share IPD with other researchers. There have been no requests to share data.
Publications
Koethe JR, Jenkins CA, Furch BD, Lake JE, Barnett L, Hager CC, Smith R, Hulgan T, Shepherd BE, Kalams SA. Brief Report: Circulating Markers of Immunologic Activity Reflect Adiposity in Persons With HIV on Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):135-140. doi: 10.1097/QAI.0000000000001768.
PubMed 29794823Grome HN, Barnett L, Hagar CC, Harrison DG, Kalams SA, Koethe JR. Association of T Cell and Macrophage Activation with Arterial Vascular Health in HIV. AIDS Res Hum Retroviruses. 2017 Feb;33(2):181-186. doi: 10.1089/AID.2016.0113. Epub 2016 Sep 14.
PubMed 27527002Koethe JR, Jenkins CA, Petucci C, Culver J, Shepherd BE, Sterling TR. Superior Glucose Tolerance and Metabolomic Profiles, Independent of Adiposity, in HIV-Infected Women Compared With Men on Antiretroviral Therapy. Medicine (Baltimore). 2016 May;95(19):e3634. doi: 10.1097/MD.0000000000003634.
PubMed 27175676Koethe JR, Grome H, Jenkins CA, Kalams SA, Sterling TR. The metabolic and cardiovascular consequences of obesity in persons with HIV on long-term antiretroviral therapy. AIDS. 2016 Jan 2;30(1):83-91. doi: 10.1097/QAD.0000000000000893.
PubMed 26418084Masenga SK, Elijovich F, Hamooya BM, Nzala S, Kwenda G, Heimburger DC, Mutale W, Munsaka SM, Zhao S, Koethe JR, Kirabo A. Elevated Eosinophils as a Feature of Inflammation Associated With Hypertension in Virally Suppressed People Living With HIV. J Am Heart Assoc. 2020 Feb 18;9(4):e011450. doi: 10.1161/JAHA.118.011450. Epub 2020 Feb 17.
PubMed 32064996
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of Adipose Tissue and Immune Activation in Treated HIV Infection
- ClinicalTrials.gov ID
- NCT04439448
- Acronym / sponsor ID
- AIAC / K23AI100700
- Conditions
- Human Immunodeficiency Virus, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 12 Apr 2013 (actual)
- Primary completion
- 3 Nov 2014 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 19 Jun 2020 (actual)
- 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 prevalence of HIV-associated wasting declined dramatically with the introduction of effective antiretroviral therapy (ART), but as patients survive longer on treatment the proportion of overweight (body mass index [BMI] >25 kg/m2) and obese (BMI >30 kg/m2) HIV-infected individuals has been rising over time and is reaching parity with the general population. Adipose tissue has broad effects on immune function relevant to HIV infection, including the basal inflammatory state and peripheral lymphocyte populations, but there are few data on the effects of high adiposity on HIV immunology. This issue is directly relevant to promoting the long-term health of ART-treated individuals, many of which can now survive for decades on treatment, as emerging evidence suggests that increased immune activation is a major risk factor for the development of cardiovascular and metabolic diseases in this population. HIV-infected individuals on ART have an approximately 2-fold higher risk of myocardial infarction and a 4-fold higher risk of type 2 diabetes mellitus, and the proportion of deaths among HIV-infected individuals due to non-AIDS conditions now exceeds those due to AIDS.
Despite the increasing proportion of overweight and obese HIV-infected persons, few prior studies have investigated the interaction between adipose tissue, immune activation, and risk factors for cardiovascular and metabolic disease in treated HIV. The overall goal of this study is to understand the complex relationships between adipose tissue, innate and cellular immune activation, and metabolic and cardiovascular disease risk factors in persons on long-term antiretroviral therapy. To this end, we will use an observational, cross-sectional cohort design to compare in vivo markers of immune activation, ex vivo cytokine expression, and metabolic and cardiovascular disease markers in HIV-infected individuals with a range of body composition profiles and between overweight/obese HIV-infected and uninfected individuals.
Detailed description
HIV-infected individuals on long-term ART treatment are at increased risk for many diseases, particularly diabetes mellitus and coronary artery disease, which are more commonly associated with obesity and a sedentary lifestyle. As HIV patients are now living longer on effective treatment, a growing proportion are becoming overweight and obese, and the management of non-AIDS chronic diseases associated is emerging as a major challenge to clinicians and the health care system. Excess adiposity (i.e., being overweight or obese) and treated HIV infection are associated with strikingly similar alterations in inflammatory biomarkers and cellular immune function implicated in the pathogenesis of chronic diseases, but there are few data at present on whether the effects of obesity and treated HIV are synergistic or additive. In this study we will closely investigate the effects of adipose tissue on both the innate and cellular arms of the immune system, and the relationships between adiposity, immune function, and risk factors for metabolic and cardiovascular diseases.
Heightened, chronic systemic inflammation is an important contributor to non-AIDS related morbidity and mortality among patients on ART, and treated HIV and obesity may promote increased metabolic and cardiovascular disease through similar mechanisms. Elevated serum highly-sensitive C-reactive protein (hsCRP; a more sensitive serum CRP assay used to measure inflammation), interleukin-6 (IL-6), and other innate immune-derived inflammatory markers are independently associated with increased risk of cardiovascular events, insulin resistance, and all-cause death among HIV-infected individuals. The etiology of this HIV-associated inflammation is not fully understood and likely multifactorial, but serum hsCRP and several proinflammatory cytokines (e.g., IL-6, TNF-α receptor 1) correlate with fat mass in HIV-infected adults, suggesting adipose tissue may have a role in modulating the inflammatory response.
In addition to greater inflammation, abdominal obesity is associated with altered T cell function, characterized by increased circulating markers of cellular immune activation (e.g., sCD25 and neopterin), and adipose tissue biopsies from obese individuals and animal models contain higher numbers of resident macrophages, T cells (particularly CD8+ cells) and reduced T-regulatory cells. Furthermore, adipokines (hormones produced by adipocytes), demonstrate a range of lymphocyte effects. Leptin, in particular, enhances expression of T cell activation markers after PHA stimulation, polarizes naïve CD4+ T cell proliferation towards the Th1 phenotype, and promotes Th1 cytokine production. These in vitro data are consistent with obesity modulating T cell activation, at least in part through adipokine effects.
The goal of this study is to understand the complex relationships between adipose tissue, innate and cellular immune activation, and metabolic and cardiovascular disease risk factors in persons on long-term antiretroviral therapy. Using the facilities and resources of the Vanderbilt Clinical Research Center, we will enroll an observational cohort to investigate the interactions of innate immune activation, metabolic and cardiovascular risk factors, and T cell activation among HIV-infected and uninfected adults with a range of body composition profiles from low adiposity (lean) to high adiposity (obese). The study groups will be comprised of 70 HIV-infected adults on ART with a range of body composition profiles from low adiposity (lean) to high adiposity (obese), and a control group of 30 overweight and obese uninfected individuals.
Hypothesis 1: Increased adipose tissue promotes increased innate and cellular immune activation in HIV-infected individuals on long-term ART.
Specific Aim 1a: To study the hypothesis that adipose tissue promotes innate immune activation in treated HIV by determining if serum leptin (a marker of adiposity) is positively associated with interleukin-6 (IL-6) levels, in addition to other inflammation biomarkers (including C-reactive protein), in HIV-infected persons on long-term ART with a range of body composition profiles from low adiposity (lean) to high adiposity (obese).
Specific Aim 1b: To study the hypothesis that adipose tissue promotes cellular immune activation in treated HIV by determining if serum leptin is positively associated with the percentage of CD8+ T cells expressing CD38 and HLA-DR activation markers in HIV-infected persons on long-term ART.
Hypothesis 2: Overweight and obese HIV-infected individuals on long-term ART have significantly greater markers of innate and cellular immune activation compared to uninfected individuals with equivalent adiposity.
Specific Aim 2a: To determine if IL-6 serum levels, and other inflammation biomarkers, are significantly higher among overweight/obese HIV-infected persons compared to uninfected controls with equivalent adiposity.
Specific Aim 2b: To determine if the percentage of CD38+ and HLA-DR+ CD8+ T cells is significantly higher among overweight/obese HIV-infected persons compared to uninfected controls with equivalent adiposity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV+ non-obese | – | Radiation: dual-energy X-ray absorptiometry (DEXA) scan, Other: Carotid and branchial artery ultrasound, Diagnostic Test: 2-hour oral glucose tolerace test, Diagnostic Test: Blood collectionHIV+ adults on antiretroviral therapy with a body mass index <30 kg/m2 |
| HIV+ obese | – | Radiation: dual-energy X-ray absorptiometry (DEXA) scan, Other: Carotid and branchial artery ultrasound, Diagnostic Test: 2-hour oral glucose tolerace test, Diagnostic Test: Blood collectionHIV+ adults on antiretroviral therapy with a body mass index >=30 kg/m2 |
| HIV-negative obese | – | Radiation: dual-energy X-ray absorptiometry (DEXA) scan, Other: Carotid and branchial artery ultrasound, Diagnostic Test: 2-hour oral glucose tolerace test, Diagnostic Test: Blood collectionHIV-negative adults on antiretroviral therapy with a body mass index >=30 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health persons with HIV receiving care at the Vanderbilt Comprehensive Care Clinic and healthy persons without HIV receiving care at Vanderbilt University Medical Center
Key inclusion criteria (9 listed)
- age >18 years
- on ART >2 years
- a CD4+ nadir >100 cells/µl prior to starting ART
- a CD4 >350 cells/µl at the time of enrollment
- HIV-1 viral load <50 copies/ml
Key exclusion criteria (5 listed)
- Pregnant (women only)
- Current use of anti-diabetic medications or statins
- Pregnant (women only)
- Current use of anti-diabetic medications or statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual-energy X-ray absorptiometry (DEXA) scanWhole body dual-energy X-ray absorptiometry (DEXA) scan to assess lean and fat mass | Radiation | HIV+ non-obese, HIV+ obese, HIV-negative obese |
| Carotid and branchial artery ultrasoundUltrasound to assess carotid plaque and brachial artery flow mediated dilation | Other | HIV+ non-obese, HIV+ obese, HIV-negative obese |
| 2-hour oral glucose tolerace testIngestion of 75g of glucose syrup with blood collection for glucose and insulin at time 0, 90min and 120min | Diagnostic test | HIV+ non-obese, HIV+ obese, HIV-negative obese |
| Blood collectionBlood collection for measurement of circulating proteins (cytokines) and isolation of immune cells | Diagnostic test | HIV+ non-obese, HIV+ obese, HIV-negative obese |
Primary outcome
CD38+ CD4+ T cells
Time frame: At study enrollment
Flow cytometry measurement of CD38 expression on isolated CD4+ T cells
Plasma interleukin-6
Time frame: At study enrollment
Level of circulating interleukin-6
3 secondary outcomes
Carotid intima media thickness
Time frame: At study enrollment
Brachial artery maximal flow mediated dilation
Time frame: At study enrollment
Visceral adipose tissue volume (cm3)
Time frame: At study enrollment
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 19 Jun 2020.
- Results publication: PubMed 29794823Koethe JR, Jenkins CA, Furch BD, Lake JE, Barnett L, Hager CC, Smith R, Hulgan T, Shepherd BE, Kalams SA. Brief Report: Circulating Markers of Immunologic Activity Reflect Adiposity in Persons With HIV on Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):135-140. doi: 10.1097/QAI.0000000000001768.
- Results publication: PubMed 27527002Grome HN, Barnett L, Hagar CC, Harrison DG, Kalams SA, Koethe JR. Association of T Cell and Macrophage Activation with Arterial Vascular Health in HIV. AIDS Res Hum Retroviruses. 2017 Feb;33(2):181-186. doi: 10.1089/AID.2016.0113. Epub 2016 Sep 14.
- Results publication: PubMed 27175676Koethe JR, Jenkins CA, Petucci C, Culver J, Shepherd BE, Sterling TR. Superior Glucose Tolerance and Metabolomic Profiles, Independent of Adiposity, in HIV-Infected Women Compared With Men on Antiretroviral Therapy. Medicine (Baltimore). 2016 May;95(19):e3634. doi: 10.1097/MD.0000000000003634.
- Results publication: PubMed 26418084Koethe JR, Grome H, Jenkins CA, Kalams SA, Sterling TR. The metabolic and cardiovascular consequences of obesity in persons with HIV on long-term antiretroviral therapy. AIDS. 2016 Jan 2;30(1):83-91. doi: 10.1097/QAD.0000000000000893.
- Results publication: PubMed 32064996Masenga SK, Elijovich F, Hamooya BM, Nzala S, Kwenda G, Heimburger DC, Mutale W, Munsaka SM, Zhao S, Koethe JR, Kirabo A. Elevated Eosinophils as a Feature of Inflammation Associated With Hypertension in Virally Suppressed People Living With HIV. J Am Heart Assoc. 2020 Feb 18;9(4):e011450. doi: 10.1161/JAHA.118.011450. Epub 2020 Feb 17.
- Individual participant dataSharing planned: No. There is no plan at this time to share IPD with other researchers. There have been no requests to share data.
Related trials for Human Immunodeficiency Virus
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
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.
John Koethe, MD principal investigator
Vanderbilt University Medical Center
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 Human Immunodeficiency Virus and Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
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 5 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 19 Jun 2020. 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 United States. 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?
CD38+ CD4+ T cells (time frame: At study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439448, which also lists 5 linked publications.
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 19 Jun 2020.