Health Condition 1: null- HIV POSITIVE
Conditions
Interventions
Intervention1: PITAVASTATIN: 4MG tablets administered orally
Control Intervention1: PLACEBO OF PITAVASTATIN: 4MG administered orally
Sponsors
NIH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Documentation ofHIV-1 infection by means of any one of the following: .Documentation of HIV diagnosis in the medical record by a licensed health care provider; • OR HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL; • OR any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid Multispot antibody differentiation assay. 2. Combination antiretroviral therapy (ART) for at least 180 days prior to study entry. 3. CD4+ cell count >100 cells/mm3 obtainedwithin 180 days prior to study entry. 4. Laboratory values drawn at screen and/or obtained from clinical care (as indicated in section 6.1 Schedule of Events) within 90days prior to study entry. • Fasting LDL cholesterol as follows ASCVD RISK SCORE LDL CHOLESTEROL >7.5%- >10%- >15% If LDL Less that 70mg/dl participant is eligible regardless of ASCVD RISK SCORE • Fasting triglycerides • Hemoglobin ï?³8 g/dL for female subjects and ï?³9 g/dL for male subjects • Calculated creatinine clearance (CrCl) ï?³60 mL/min OR Glomerular filteration rate (GFR)more than 60 ml/min/1.73m2 • ALT NOTE:Subjects co-infected with chronic active hepatitis B or C must have ALT 5. For persons with known chronic active hepatitis B or C, calculated FIB-4 score must be NOTE: Active is defined as hepatitis B surface antigen positive, hepatitis B DNA positive, or hepatitis C RNA positive. 6. Female subjects of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within 24 months prior to study entry, and women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy) must have a negative serum or urine pregnancy test within 48 hours prior to entry NOTE: Subject-reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, andmenopause. Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH (follicle stimulating hormone) of greater than 40 IU/L or, if FSH testing is not available, they have had amenorrhea for 24 consecutive months. 7. For women of reproductivepotential, willingness to use contraceptives as describedin the product information for pitavastatin. Contraceptives must be used at least two weeks before initiation of study drug and must be continued 6 weeks after cessation of study drug. If participating in sexual activity that could lead to pregnancy, women must use a form of contraceptive. At least one of the following methods must be used appropriately: • Condoms (male or female) with or withoutspermicidal agent • Diaphragm or cervical cap with spermicidal agent • Intrauterine device (IUD) • Hormone-based contraceptive • Tubal ligation • Tubal micro-inserts Women who are not of reproductive potential as defined
Exclusion criteria
Exclusion criteria: 1.Clinical ASCVD, as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: • AMI • Acute coronary syndromes • Stable or unstable angina • Coronary or other arterial revascularization • Stroke • TIA • Peripheral arterial disease presumed to be of atherosclerotic origin 2.Current diabetes mellitusif LDL >=70mg/dL NOTE: Current diabetes is defined by patient report of physician diagnosis. Subjects with a history of diabetes which has resolved and no longer requires therapy are not considered to have current diabetes, eg,women with a history of gestational diabetes, steroid-induced or medication-induced. 3. 10-year ASCVD risk score estimated by Pooled Cohort Equations >15% 4. Active cancer within 12 months prior to study entry. 5. Known decompensated cirrhosis. 6.History of myositis or myopathy with active disease in the 180 days prior to study entry. 7.Known untreated symptomatic thyroid disease. 8.History of allergy or severe adverse reaction to statins. 9.Use of specific immunosuppressants or immunomodulatory agents including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, TNF-alpha blockers or antagonists, azathioprine, interferon, growth factors, or intravenous immunoglobulin (IVIG) in the 30 days prior to study entry. NOTE: Use of oral prednisone 10Current use of erythromycin, colchicine, or rifampin. 11 Use of statin drugs or gemfibrozil, PCSK9 inhibitors in the 90 days prior to study entry. NOTE: Use of niacin as part of a multivitamin is not exclusionary. 12. Current use of an investigational new drugthat would be contraindicated. 13.Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry. 14.Known active or recent (not fully resolved within 30 days prior to study entry) systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human papillomavirus [HPV], or HCV). 15.Current breastfeeding. 16. Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures. 17.Other medical, psychiatric, or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures and or adherence to study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statin therapy will prevent atherosclerotic cardiovascular disease (ASCVD)-related MACE (major adverse cardiovascular events) in HIV-infected persons on antiretroviral therapy (ART) in whom traditional CVD risk is not significantly increasedTimepoint: Individual subject to be followed for up to 72 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Statin therapy will be associated with reductions in specific CVD-related events and all-cause mortality. 2.Decreases in LDL and non-HDL cholesterol levels associated with statin therapy will be predictive of reduction in CVD events. 3. Statin therapy will reduce serious non-cardiovascular events, including malignancies, end stage kidney or liver disease. 4. Statin therapy will be safe and welltolerated in the HIV-infected population. Timepoint: Individual subject will be followed for up to 72 months | — |
Countries
India, South Africa
Contacts
Public ContactDr N KUMARASAMY
YRGCARE MEDICAL CENTRE
Outcome results
None listed