Statin administration is supposed to reduce subclinical atherosclerosis by decreasing LDL cholesterol levels, possibly via lipid-independent anti-inflammatory effect. Its pleiotropic properties also adding beneficial effect against CMV infection. The investigators plan to study atorvastatin in virally- suppressed HIV-infected patients on stable ART with CMV seropositive and statin-naïve to evaluate the subclinical atherosclerosis changes assessed by carotid intima media thickness (CIMT).
Extended description of the protocol, including more technical information
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
80
The participants will get the medication supply every month along with the refill of antiretroviral drugs. The drug and placebo tablets will be administered to patients by a staff member who are privy to the treatment. In the end of every month, each participant should return the unused pills every month
Cipto Mangunkusumo General Hospital
Jakarta, Center Jakarta, Indonesia
Carotid intima medial tunica change
Numerical changes (in millimeter) between baseline and 48 weeks. Common Carotid Artery (CCA) intima media thickness measured by using B mode imaging system (Affiniti 70 series), equipped with a linear array transducer \> 7 MHz with minimal compression (\<10:1) and footprint of at least 3 cm. This procedure is operated by certified Cardiologist. Reference Siomva I. Intima-media thickness: appropriate evaluation and proper measurement, described. ESC. May 2015;15:21.
Time frame: (1) 0-week visit, (2) 48-week visit
Flow mediated vasodilatation change
Numerical changes (in percentage) between baseline and 48 weeks FMD. Using a high-resolution ultrasound linear array transducer, longitudinal images of the right brachial artery (mostly 3-15 cm above the elbow) were recorded at the baseline and for 3 minutes after cuff deflation following suprasystolic compression (50 mmHg over the systolic blood pressure) of the right forearm for 5 minutes. This procedure is operated by certified cardiologist. Reference: Charakida M, Masi S, Luscher TF, Kastelein JJ, Deanfield JE.Assessment of atherosclerosis: the role of flow-mediated dilatation.Eur Heart J. 2010 Dec;31(23):2854-61
Time frame: (1) 0-week visit, (2) 48-week visit
Liver fibrosis change
Numerical changes (in KPa) between baseline and 48 week. The measurement of liver stiffness which uses the velocity of shear waves that travel through the liver using the Fibroscan (Echosens) device. This procedure is operated by certified hepatologist.
Time frame: (1) 0-week visit, (2) 48-week visit
Liver steatosis change
Numerical changes (in dB/m) between baseline and 48 weeks. The measurement of steatosis using the Fibroscan (Echosens) equipped with CAP software. dB/m. This procedure is operated by certified hepatologist.
Time frame: (1) 0-week visit, (2) 48-week visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fasting lipid change
Numerical changes of fasting lipid profile consist of total cholesterol, LDL-C, HDL-C and triglyceride in mg/dL. Range of fasting is 8 - 10 hours. The test is located in Cipto Mangunkusumo Hospital or Prodia Laboratory Clinic.
Time frame: (1) 0-week visit, (2) 48-week visit
Neurocognitive function change
Mean or median changes of neurocognitive function change. Neurologist will do supervision while subject do the test. The measurement tool is questionnaire named "neurocognitive test". This item will comprising several aspects: 1. Trail making test 2. Symbol digit modalities test 3. Brief visuospatial memory test revised 4. California verbal learning test II
Time frame: (1) 0-week visit, (2) 24-week visit, (3) 48-week visit
Community Periodontal Index (CPI)
This Community Periodontal Index takes into consideration 10 teeth in the oral cavity i.e. 17, 16, 11, 26, 27, 37, 36, 31, 46 and 47 and subsequently evaluates the occurrence of gingival bleeding, presence of supra- and subgingival calculus, periodontal pockets with probing depths between 3.5-6.0 mm, as well as clinical attachment loss. This procedure done by dentist. CPI score: * Score 0: health periodontal conditions * Score 1: gingival bleeding on probing * Score 2: calculus and bleeding * Score 3: periodontal pocket 4-5 mm * Score 4: periodontal pocket ≥6 mm Only the worst finding from the index teeth is recorded per sextant of teeth.
Time frame: (1) 0-week visit, (2) 48-week visit
beta 2-microglobulin change
The numerical change of beta 2-microglobulin (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Time frame: (1) 0-week visit, (2) 48-week visit
Soluble CD14 change
The numerical change of sCD14 (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Time frame: (1) 0-week visit, (2) 48-week visit
ICAM-1 change
The numerical change of ICAM-1 (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Time frame: (1) 0-week visit, (2) 48-week visit
High Sensitivity C-Reactive Protein (hsCRP) change
The numerical change of hsCRP (in mg/L) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Time frame: (1) 0-week visit, (2) 48-week visit
Vascular Cell Adhesion Molecule-1 (V CAM-1) change
The numerical change of V CAM-1 (in pg/mL) between 0-week visit and 48-week visit. This examination located in Indonesian Medical Education and Research Institute (IMERI) laboratory
Time frame: (1) 0-week visit, (2) 48-week visit