ClinicalTrials.gov
ClinicalTrials.gov Menu

Ugandan Non-Communicable Diseases and Aging Cohort (UGANDAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02445079
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : September 1, 2017
Sponsor:
Collaborators:
Mbarara University of Science and Technology
University of California, San Francisco
Ragon Institute of MGH, MIT and Harvard
National Institutes of Health (NIH)
Harvard University
Information provided by (Responsible Party):
Mark Siedner, Massachusetts General Hospital

Brief Summary:
Longitudinal cohort study of older-aged people living with HIV infection in southwestern Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring the epidemiology of cardiovascular and pulmonary disease in this study setting, and particularly the contribution of HIV infection to it.

Condition or disease Intervention/treatment
HIV Cardiovascular Disease Chronic Obstructive Pulmonary Disease Atherosclerosis Hypertension Diabetes Mellitus Other: This is an observational study only

Detailed Description:

This study recruits people living with HIV/AIDS (PLWH) aged 40 and older; and an HIV-uninfected age and gender-matched, community-based comparison group in the HIV clinic catchment area.

Study investigators will collect sociodemographic, clinical, immune activation, systemic inflammation, plasma and stool microbiome, and clinical pulmonary and cardiovascular disease measures. Our outcomes of interest are measures of carotid atherosclerosis, including carotid intima media thickness and presence of plaque, prior ischemic heart disease (as measured by electrocardiograms), peripheral arterial disease (as measured by ankle-branchial index), and lung function as measured by pulmonary function testing. Our exposures of interest are traditional cardiovascular disease risk factors (e.g. age, gender, family history of cardiovascular disease, smoking history, diet, activity, body mass index, prevalence of diabetes, and prevalence of hypertension) and HIV-related cardiovascular risk factors (e.g. nadir CD4 count, ART duration and regimen, gut and plasma microbiome composition, and markers of both immune activation and systemic inflammation).

Investigators will collect this data to accomplish the following aims:

Aim 1: Compare the prevalence of atherosclerosis, measured by cIMT, ankle-brachial index, and presence of q-waves on electrocardiogram, in PLWH taking ART aged 40 and older and age and gender-matched, population-based HIV-uninfected controls. This study aims to be among the first to capture high-quality measures of atherosclerotic disease among a population of PLWH in sub-Saharan Africa. The study aims to test the hypothesis that older-age Ugandans on ART will have thicker carotid intima media, higher prevalence of peripheral arterial disease, and higher prevalence of pathologic q-waves on electrocardiogram than age and gender-matched, HIV-uninfected controls.

Aim 2: Evaluate correlates of atherosclerosis in older-age PLWH on ART, including both traditional (age, gender, smoking, diabetes and hypertension prevalence) and HIV-related risk factors (immune activation, systemic inflammation, and stool and plasma microbiome composition). The study will leverage a collaboration with the Ragon Institute to perform immunologic and molecular testing for microbial translocation and markers of immune activation and systemic inflammation (e.g. soluble CD163, C-reactive protein, IL-6, CD8+ T-lymphocyte activation).

Aim 3: Compare the progression of atherosclerosis in PLWH versus HIV-uninfected individuals over five years of observation time. The study aims to test the hypothesis that the rate of change in carotid intima media thickness will be faster in among PLWH over 45 on ART than age and gender-matched HIV-uninfected controls, and that rates of change in carotid intima media thickness among the HIV-infected cohort will be associated with markers of microbial translocation, immune activation, and systemic inflammation.

Aim 4: Compare the prevalence and incidence of abnormal pulmonary function (FEV1, FVC, FEV1/FVC) in PLWH on ART and age- and gender-matched, population-based HIV-uninfected controls, utilizing handheld spirometry with bronchodilator challenge. The study aims to test the hypothesis that pulmonary function is worse and COPD is more common among people living with HIV/AIDS than age- and gender-match HIV-uninfected controls.


Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Atherosclerosis Among Older-Age People in Southwestern Uganda
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV infected
HIV infected sub-group
Other: This is an observational study only
Observational study only

HIV uninfected
HIV uninfected sub-group, age and gender matched to the HIV-infected group
Other: This is an observational study only
Observational study only




Primary Outcome Measures :
  1. Baseline prevalence and incident change in carotid intima media thickness [ Time Frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months) ]
    Measured by carotid ultrasonography


Secondary Outcome Measures :
  1. Baseline prevalence and incident change in carotid plaque [ Time Frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months) ]
    Measured by carotid ultrasonography

  2. Baseline prevalence and incident change in ischemic heart disease [ Time Frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months) ]
    Measured by electrocardiography

  3. Baseline prevalence and incident change in peripheral arterial disease [ Time Frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months) ]
    Measured by ankle branchial index

  4. Baseline prevalence and incident change in chronic obstructive pulmonary disease [ Time Frame: Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months) ]
    Measured by pulmonary function testing


Biospecimen Retention:   Samples Without DNA
Annual collection of serum, plasma, and stool.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study recruits two sub-groups of participants:

Study Group 1:

-HIV infected persons aged 40 and older, in care at the Immune Suppression Syndrome HIV Clinic at Mbarara Regional Referral Hospital

Study Group 2:

-Community-based, HIV uninfected persons recruited from the catchment area of the Mbarara Regional Referral Hospital (greater Mbarara), and age and gender-matched to Group 1 participants

Criteria

Group 1 Inclusion Criteria:

  • HIV infected
  • Age > 40 years old at enrollment
  • Minimum 2 years of antiretroviral therapy

Group 1 Exclusion Criteria:

  • Decline informed consent

Group 2 Inclusion Criteria:

  • Living in catchment area of Mbarara Regional Referral Hospital (greater Mbarara)
  • Age > 40 years old
  • Age and gender matched to a participant in group 1

Group 2 Exclusion Criteria:

  • HIV infection (tested annually as part of study procedures)
  • Decline informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445079


Contacts
Contact: Mark J Siedner, MD MPH 617-726-4686 msiedner@mgh.harvard.edu

Locations
Uganda
Mbarara University of Science and Technology Recruiting
Mbarara, Uganda
Contact: Okello Samson, MD    +256-485-21623    okello.samson@must.ac.ug   
Sponsors and Collaborators
Massachusetts General Hospital
Mbarara University of Science and Technology
University of California, San Francisco
Ragon Institute of MGH, MIT and Harvard
National Institutes of Health (NIH)
Harvard University
Investigators
Principal Investigator: Mark J Siedner, MD MPH Massachusetts General Hospital

Responsible Party: Mark Siedner, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02445079     History of Changes
Other Study ID Numbers: 2014P001928
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Lung Diseases
Cardiovascular Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Arteriosclerosis