CMV
Conditions
Keywords
statin, atherosclerosis
Brief summary
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).
Detailed description
Extended description of the protocol, including more technical information
Interventions
DRUGAtorvastatin - placebo controlled clinical trial
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
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
Subjects with undetectable HIV-RNA, positive anti-CMV, having Framingham Risk Score above 10% with LDL \< 130 or under 10% with LDL \<160 will undergo thorough medical history and anthropometric examination as the initial data. Patient will be seen for regular clinical follow up as standard of care in the clinic (monthly/ bimonthly). Follow up visit will include clinical and laboratory procedure. At week 24, blood collection procedures and neurocognitive examination procedures will be repeated. At week 48, blood collection procedures, CIMT, FMD, transient elastography with CAP, and neurocognitive examination procedures will be repeated.
Intervention model description
Atorvastatin tablets in generic form. The placebo tablets will be prepared by Cipto Mangunkusumo hospital pharmacist, were composed of starch and were similar to atorvastatin tablets in size, shape, and colour. 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages between 20 to 45 years old * Using stable ART at least 1 year * Positive IgG CMV * Viral load HIV RNA \<50 copies / ml
Exclusion criteria
* Undergoing hepatitis C DAA therapy * Decompensated cirrhosis or acute liver failure * History of coronary artery disease * Diabetes mellitus * History of of brain infection, epilepsy, stroke * History of rhabdomyolysis or myopathy * Pregnant or breastfeeding * Severe depression * Using statin therapy in the past 6 weeks * History of statin hypersensitivity * Framingham Risk Score above 10% within LDL ≥130 * Framingham Risk Score under 10% within LDL ≥160 * Out of Periodontitis Index (Upper right molars, top series, upper left molars, lower right molars, bottom series, lower left molars)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid intima medial tunica change | (1) 0-week visit, (2) 48-week visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow mediated vasodilatation change | (1) 0-week visit, (2) 48-week visit | 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 |
| Liver fibrosis change | (1) 0-week visit, (2) 48-week visit | 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. |
| Liver steatosis change | (1) 0-week visit, (2) 48-week visit | 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. |
| Fasting lipid change | (1) 0-week visit, (2) 48-week visit | 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. |
| Neurocognitive function change | (1) 0-week visit, (2) 24-week visit, (3) 48-week visit | 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 |
| Community Periodontal Index (CPI) | (1) 0-week visit, (2) 48-week visit | 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. |
| beta 2-microglobulin change | (1) 0-week visit, (2) 48-week visit | 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 |
| Soluble CD14 change | (1) 0-week visit, (2) 48-week visit | 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 |
| ICAM-1 change | (1) 0-week visit, (2) 48-week visit | 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 |
| High Sensitivity C-Reactive Protein (hsCRP) change | (1) 0-week visit, (2) 48-week visit | 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 |
| Vascular Cell Adhesion Molecule-1 (V CAM-1) change | (1) 0-week visit, (2) 48-week visit | 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 |
Countries
Indonesia
Outcome results
None listed