Cardiovascular Prevention for Persons With HIV

Hennepin Healthcare

Status: Completed

Conditions: HIV Infection; Cardiovascular Disease Risk

Treatments: Drug: Pravastatin; Drug: Lisinopril

Study type: Interventional

Funder types: Other

Identifiers

NCT00982189

PCC-003

Details and patient eligibility

About

This study is funded by the American Heart Association. The goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with HIV infection. Evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with HIV infection).

Participants who are taking HIV treatment with an 'undetectable' viral load, and who do NOT need treatment for high blood pressure or cholesterol may be eligible to enroll. Participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.

Enrollment: 37 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV Infection with viral load 'undetectable' while taking antiretroviral therapy
• Age ≥40
• Framingham risk score (FRS) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy

Exclusion criteria

• Known cardiovascular disease or Framingham risk score (FRS) ≥20%
• Blood pressure ≥140/90
• LDL cholesterol ≥160 (with FRS <10%), or ≥130 (with FRS 10-20%)
• Currently taking, or has a medication contraindication to take, a 'statin', an ACE inhibitor, or an angiotensin receptor blocker medication
• Cirrhosis or plasma ALT/AST levels >2x upper limit of normal
• Chronic kidney disease and a creatinine >2.0mg/dL
• Triglycerides >500mg/dL

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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37 participants in 4 patient groups, including a placebo group

Lisinopril

Experimental group

Description:

Lisinopril 10mg once daily

Treatment:

Drug: Lisinopril

Lisinopril Placebo

Placebo Comparator group

Description:

Placebo pill (matched to lisinopril) once daily

Treatment:

Drug: Lisinopril

Pravastatin

Experimental group

Description:

Pravastatin 20mg once daily

Treatment:

Drug: Pravastatin

Pravastatin placebo

Placebo Comparator group

Description:

Placebo pill (matched to pravastatin) once daily

Treatment:

Drug: Pravastatin