Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
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ClinicalTrials.gov Identifier: NCT01407237 |
Recruitment Status
:
Completed
First Posted
: August 2, 2011
Last Update Posted
: August 5, 2016
|
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Condition or disease | Intervention/treatment |
---|---|
HIV-infection | Drug: Angiotensin II Infusion |
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | March 2015 |

Group/Cohort | Intervention/treatment |
---|---|
HIV-infected Individuals |
Drug: Angiotensin II Infusion
Angiotensin II (Bachem) will be infused at 0.3 ng/kg/min for 30 minutes, then 1.0 ng/kg/min for 30 minutes, then 3.0 ng/kg/min for 30 minutes; at baseline and at each infusion concentration, serum aldosterone will be measured. BP and heart rate will be monitored at baseline and every 2 minutes during the infusion.
|
non-HIV-infected Individuals |
Drug: Angiotensin II Infusion
Angiotensin II (Bachem) will be infused at 0.3 ng/kg/min for 30 minutes, then 1.0 ng/kg/min for 30 minutes, then 3.0 ng/kg/min for 30 minutes; at baseline and at each infusion concentration, serum aldosterone will be measured. BP and heart rate will be monitored at baseline and every 2 minutes during the infusion.
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- 24-hour urine aldosterone to creatinine ratio [ Time Frame: baseline ]
- Plasma Renin Activity [ Time Frame: baseline ]
- Aldosterone response to Angiotensin II Infusion [ Time Frame: baseline ]
- Flow mediated dilation [ Time Frame: baseline ]
- Intramyocellular Lipid [ Time Frame: baseline ]
- Hepatic fat [ Time Frame: baseline ]
- Insulin stimulated glucose uptake [ Time Frame: baseline ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Stable use of antiretroviral therapy for at least 3 months (HIV group)
- Age ≥ 18 and ≤ 65 years of age
Exclusion Criteria:
- 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

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): NCT01407237
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01407237 History of Changes |
Other Study ID Numbers: |
2011P000250 |
First Posted: | August 2, 2011 Key Record Dates |
Last Update Posted: | August 5, 2016 |
Last Verified: | August 2016 |
Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
HIV-infection renin aldosterone visceral fat |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Angiotensin II Angiotensinogen Vasoconstrictor Agents Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |