REPRIEVE STUDY (A5332 PROTOCOL)
- Conditions
- -B24 Unspecified human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseB24
- Registration Number
- PER-012-17
- Lead Sponsor
- Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
Documentation of HIV-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.
NOTE: A licensed” assay refers to a US FDA-approved assay, which is required for all IND studies. Non-US sites are encouraged to use FDA-approved methods; if not available, then each non-US site must use an assay that has been certified or licensed by an oversight body within that country and validated internally.
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.
Combination antiretroviral therapy (ART) for at least 180 days prior to study entry.
NOTE:Treatment interruptions for up 14 days total in the last 180 days are permitted as long as the subject has been continuously on therapy for the 30 days prior to study entry.
CD4+ cell count >100 cells/mm3 obtained within 180 days prior to study entry at any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices and participates in appropriate external quality assurance programs.
Laboratory values drawn at screen and/or obtained from clinical care (as indicated in section 6.1 Schedule of Events) within 90 days prior to study entry at any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices and participates in appropriate external quality assurance programs.
•Fasting LDL cholesterol <190 mg/dL
NOTE: For those with an ASCVD risk score ≥7.5% and ≤10%, LDL cholesterol must be <160 mg/dL. For those with an ASCVD risk score >10%, LDL cholesterol must be <70 mg/dL.
•Fasting triglycerides <500 mg/dL
•Hemoglobin 8 g/dL for female subjects and 9 g/dL for male subjects
•Calculated creatinine clearance (CrCl) 60 mL/min, as estimated by the Cockcroft-Gault equation
NOTE: Refer to the calculator for the Cockcroft-Gault equation in the MOPS.
•ALT ≤2.5 x ULN
NOTE: Subjects co-infected with chronic active hepatitis B or C must have ALT ≤2 x ULN.
For persons with known chronic active hepatitis B or C, calculated FIB-4 score must be ≤3.25.
NOTE:Active is defined as hepatitis B surface antigen positive, hepatitis B DNA positive, or hepatitis C RNA positive.
NOTE:Refer to the calculator for the FIB-4 equation in the MOPS.
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 u
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
Current diabetes mellitus if LDL ≥70 mg/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.
10-year ASCVD risk score estimated by Pooled Cohort Equations >10%
NOTES:
•The ACC/AHA 2013 Prevention Guidelines Calculator Tool link is located in section 6.3.4.
•For those with a 10-year ASCVD risk score ≥7.5% and ≤10%, LDL cholesterol must be <160 mg/dL.
•Subjects with ASCVD risk score >10% who also have an LDL cholesterol level <70 mg/dL would, however, be permitted to enroll, in line with the 2013 ACC/AHA Cholesterol Guidelines.
Active cancer within 36 months prior to study entry.
NOTE: Subjects with successfully treated non-melanomatous skin cancer within 36 months prior to study entry are acceptable. Disseminated Kaposi Sarcoma (visceral organ involvement) within the past 36 months is exclusionary.
Known cirrhosis.
History of myositis or myopathy with active disease in the 180 days prior to study entry.
Known untreated symptomatic thyroid disease.
History of allergy or severe adverse reaction to statins.
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 ≤10 mg/day is allowed.
NOTE: Refer to the MOPS for clarification regarding medications in these categories.
Current use of erythromycin, colchicine, or rifampin.
Use of any lipid-lowering agents, including statin drugs, fibrates, ezetimibe, red yeast rice, niacin, bile acid sequestrants, PCSK9 inhibitors, or omega-3 fatty acids (>3 grams/day in standalone formulations) in the 90 days prior to study entry.
NOTE: Use of niacin as part of a multivitamin is not exclusionary.
Current use of an investigational new drug that would be contraindicated.
NOTE: Please contact the protocol core team via e-mail as described in the Study Management section for guidance on coenrollment of subjects on investigational new drugs.
Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry.
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).
Current breastfeeding.
Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method