Effect of Atorvastatin on Subclinical Atherosclerosis

NCT04101136 | Unknown DMC

• 2 other identifiers: 19-03-0272KET-265/UN2.F1/ETIK
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

CMV

Keywords

statin; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  (1) 0-week visit, (2) 48-week visit

Secondary Outcomes (11)

• Flow mediated vasodilatation change

  (1) 0-week visit, (2) 48-week visit

• Liver fibrosis change

  (1) 0-week visit, (2) 48-week visit

• Liver steatosis change

  (1) 0-week visit, (2) 48-week visit

• Fasting lipid change

  (1) 0-week visit, (2) 48-week visit

• Neurocognitive function change

  (1) 0-week visit, (2) 24-week visit, (3) 48-week visit

Study Arms (2)

Atorvastatin 20 mg

ACTIVE COMPARATOR

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.

Drug: Atorvastatin - placebo controlled clinical trial

Placebo 20 mg

PLACEBO COMPARATOR

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.

Drug: Atorvastatin - placebo controlled clinical trial

Interventions

Atorvastatin - placebo controlled clinical trial DRUG

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

Also known as: Ator-Placebo

Atorvastatin 20 mg; Placebo 20 mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages between 20 to 45 years old
• Using stable ART at least 1 year
• Positive IgG CMV
• Viral load HIV RNA \<50 copies / ml

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta, Center Jakarta, 10340, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 29067253 RESULT

• Yunihastuti E, Rusdi L, Syahrir Azizi M, Estiasari R, Jasirwan COM, Wulandari EAT, Purnamasari D, Shinta Noviar M, Aman Nasution S. Effect of atorvastatin on subclinical atherosclerosis in virally-suppressed HIV-infected patients with CMV seropositivity: a randomized double-blind placebo-controlled trial. F1000Res. 2023 Sep 15;10:151. doi: 10.12688/f1000research.28262.2. eCollection 2021.

  PMID: 37772075 DERIVED

Related Links

• Chastain DB, Kayl RS, Daniel MR. Evidence-based review of statin use in patients with HIV on antiretroviral therapy. J Clin Transl Endocrinol. 2017;8:6-14.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allergy- Immunology Consultant

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 24, 2019
• Study Start: September 30, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2021
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

ID (1)