Clinical trial NCT04101136: Effect of Atorvastatin on Subclinical Atherosclerosis
Official title: Effect of Atorvastatin on Subclinical Atherosclerosis in Virally-suppressed HIV-infected Patients With CMV Seropositivity: a Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CMV
Keywords: statin
atherosclerosis
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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

Eligibility criteria: 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)

Primary outcomes:
measure: Carotid intima medial tunica change
timeFrame: (1) 0-week visit, (2) 48-week visit
Secondary outcomes:
measure: Flow mediated vasodilatation change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: Liver fibrosis change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: Liver steatosis change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: Fasting lipid change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: Neurocognitive function change
timeFrame: (1) 0-week visit, (2) 24-week visit, (3) 48-week visit
measure: Community Periodontal Index (CPI)
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: beta 2-microglobulin change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: Soluble CD14 change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: ICAM-1 change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: High Sensitivity C-Reactive Protein (hsCRP) change
timeFrame: (1) 0-week visit, (2) 48-week visit
measure: Vascular Cell Adhesion Molecule-1 (V CAM-1) change
timeFrame: (1) 0-week visit, (2) 48-week visit
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: Center Jakarta
Study officials:
References:
citation: Chastain DB, Stover KR, Riche DM. Evidence-based review of statin use in patients with HIV on antiretroviral therapy. J Clin Transl Endocrinol. 2017 Feb 22;8:6-14. doi: 10.1016/j.jcte.2017.01.004. eCollection 2017 Jun.