Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04439448 · ClinicalTrials.gov registry record
Adipose Tissue and Immune Activation in HIV
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 100
- Enrollment target
NCT04439448: Completed study, sponsored by Vanderbilt University Medical Center.
NCT04439448 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04439448 has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study 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 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 uninfect
Primary Outcome
Flow cytometry measurement of CD38 expression on isolated CD4+ T cells
Interventions
- DIAGNOSTIC_TEST Blood collection
- RADIATION dual-energy X-ray absorptiometry (DEXA) scan
- OTHER Carotid and branchial artery ultrasound
- DIAGNOSTIC_TEST 2-hour oral glucose tolerace test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-04-12 |
| Est. Completion | 2020-02-15 |
What the finished NCT04439448 record still lists
NCT04439448 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Blood collection is the first listed.
NCT04439448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04439448 about?
NCT04439448 is a clinical study titled "Adipose Tissue and Immune Activation in HIV". 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 r...
What is the current status of trial NCT04439448?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2013-04-12. Estimated completion is 2020-02-15.
What interventions are being tested in trial NCT04439448?
The interventions under investigation include: Blood collection (DIAGNOSTIC_TEST), dual-energy X-ray absorptiometry (DEXA) scan (RADIATION), Carotid and branchial artery ultrasound (OTHER), 2-hour oral glucose tolerace test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04439448?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI