Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV



Status:Completed
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:January 2012

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The purpose of this study is to see if individuals with HIV-infection, particularly those
with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis.
Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the
body, and they may also have effects on sugar metabolism and cardiovascular health. There is
some evidence that individuals with HIV-associated abdominal fat accumulation may have
increased aldosterone, which may contribute to abnormalities in sugar metabolism and
increased cardiovascular disease seen in HIV. The purpose of this study is the measure
renin, angiotensin, and aldosterone activity, as well as other hormonal axes, in people with
and without HIV infection, and with and without increased belly fat. The investigators
hypothesize that aldosterone will be increased in HIV-infected individuals compared to those
without HIV-infection, and that aldosterone will be further increased in HIV-infected
individuals with increased abdominal fat compared to those without abdominal fat
accumulation.


Inclusion Criteria:

1. Stable use of antiretroviral therapy for at least 3 months (HIV group)

2. Age ≥ 18 and ≤ 65 years of age

Exclusion Criteria:

1. Antihypertensive use, including angiotensin converting enzyme inhibitors or
angiotensin II receptor blocker use, diuretics, beta-blockers, calcium-channel
blockers, potassium supplements, and spironolactone; and/or blood pressure (BP)
>140/90 at screen

2. Current or recent steroid use within last 2 months.

3. Known diabetes and/or use of antidiabetic medications

4. Creatinine > 1.5 mg/dL

5. Potassium (K) > 5.5 mEq/L

6. Hemoglobin (Hgb) < 11.0 mg/dL

7. Alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN)

8. Thyroid disease/abnormal thyroid stimulating hormone (TSH)

9. Significant electrocardiographic abnormalities at screen such as heart block or
ischemia

10. History of congestive heart failure, stroke, myocardial infarction, or known coronary
artery disease (CAD)

11. For women: Pregnant or actively seeking pregnancy, or breastfeeding

12. Estrogen, progestational derivative, growth hormone (GH), growth hormone releasing
hormone (GHRH) or ketoconazole use within 3 months.

13. Current viral, bacterial or other infections (excluding HIV)

14. Current cigarette smoker/use of nicotine (patch/gum) or current active substance
abuse
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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