Status:
COMPLETED
Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
Lead Sponsor:
Massachusetts General Hospital
Conditions:
HIV-infection
Eligibility:
All Genders
18-65 years
Brief Summary
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, an...
Eligibility Criteria
Inclusion
- Stable use of antiretroviral therapy for at least 3 months (HIV group)
- Age ≥ 18 and ≤ 65 years of age
Exclusion
- 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
- Current or recent steroid use within last 2 months.
- Known diabetes and/or use of antidiabetic medications
- Creatinine \> 1.5 mg/dL
- Potassium (K) \> 5.5 mEq/L
- Hemoglobin (Hgb) \< 11.0 mg/dL
- Alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN)
- Thyroid disease/abnormal thyroid stimulating hormone (TSH)
- Significant electrocardiographic abnormalities at screen such as heart block or ischemia
- History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease (CAD)
- For women: Pregnant or actively seeking pregnancy, or breastfeeding
- Estrogen, progestational derivative, growth hormone (GH), growth hormone releasing hormone (GHRH) or ketoconazole use within 3 months.
- Current viral, bacterial or other infections (excluding HIV)
- Current cigarette smoker/use of nicotine (patch/gum) or current active substance abuse
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01407237
Start Date
January 1 2012
Last Update
August 5 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114