Effect of Atorvastatin on Subclinical Atherosclerosis

Dr Cipto Mangunkusumo General Hospital

Status: Unknown

Conditions: CMV

Treatments: Drug: Atorvastatin - placebo controlled clinical trial

Study type: Interventional

Funder types: Other

Identifiers

NCT04101136

KET-265/UN2.F1/ETIK (Registry Identifier)

19-03-0272

Details and patient eligibility

About

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).

Full description

Extended description of the protocol, including more technical information

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Atorvastatin 20 mg

Active Comparator group

Description:

Study pharmacist will make code (A and B) for atorvastatin and placebo, then save the code in safe place. Pharmacist will record each subject as participant received A or B intervention.

Treatment:

Drug: Atorvastatin - placebo controlled clinical trial

Placebo 20 mg

Placebo Comparator group

Description:

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.

Treatment:

Drug: Atorvastatin - placebo controlled clinical trial