Adipose Tissue and Immune Activation in HIV
Completed
Conditions studied: Human Immunodeficiency Virus, Obesity
In brief
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.
Key facts
- Study ID
- NCT04439448
- Run by
- Vanderbilt University Medical Center
- People needed
- 100
- Starts
- 2013-04-12
- Expected to finish
- 2020-02-15
- Last updated by the study team
- 2020-06-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnant (women only)
- Current use of anti-diabetic medications or statins
- HIV uninfected participants:
- Inclusion Criteria:
- age >18 years
- body mass index >= 30 kg/m2
- Pre-menopausal
- Exclusion Criteria:
- Pregnant (women only)
- Current use of anti-diabetic medications or statins
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.