CMVNCT04101136
Effect of Atorvastatin on Subclinical Atherosclerosis
A study of CMV, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- CMV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Sep 2019to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 20 to 45 years old
- Using stable ART at least 1 year
- Positive IgG CMV
- Viral load HIV RNA <50 copies / ml
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo General Hospital
Jakarta, Center Jakarta, 10340
About this study
Official title: Effect of Atorvastatin on Subclinical Atherosclerosis in Virally-suppressed HIV-infected Patients With CMV Seropositivity: a Randomized Double-blind Placebo-controlled Trial
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).
Read the detailed description
Extended description of the protocol, including more technical information
- Conditions
- CMV
- Being tested
- Atorvastatin - placebo controlled clinical trial
- Keywords
- statin, atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin - placebo controlled clinical trialDrug
Also called Ator-Placebo
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Atorvastatin - placebo controlled clinical trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (1) 0-week visit, (2) 48-week visit
Secondary outcomes (11)
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
Measured: (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.
Measured: (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.
Measured: (1) 0-week visit, (2) 48-week visit
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.
Measured: (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:
- Trail making test
- Symbol digit modalities test
- Brief visuospatial memory test revised
- California verbal learning test II
Measured: (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.
Measured: (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
Measured: (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
Measured: (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
Measured: (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
Measured: (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
Measured: (1) 0-week visit, (2) 48-week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start30 Sep 2019
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evy Yunihastuti, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101136
- Sponsor's protocol ID
- 19-03-0272
- Other IDs
- KET-265/UN2.F1/ETIK
- Status last verified
- Jan 2020
- First submitted
- 28 Aug 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29067253Yunihastuti 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.
PubMed 37772075
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin on Subclinical Atherosclerosis in Virally-suppressed HIV-infected Patients With CMV Seropositivity: a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04101136
- Acronym / sponsor ID
- 19-03-0272
- Conditions
- CMV
- Keywords
- statin, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 20 mg | Active comparator | Drug: Atorvastatin - placebo controlled clinical trialStudy 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. |
| Placebo 20 mg | Placebo comparator | Drug: Atorvastatin - placebo controlled clinical trialThe 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages between 20 to 45 years old
- Using stable ART at least 1 year
- Positive IgG CMV
- Viral load HIV RNA <50 copies / ml
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin - placebo controlled clinical trialAlso: Ator-PlaceboThe 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 | Drug | Atorvastatin 20 mg, Placebo 20 mg |
Primary outcome
Carotid intima medial tunica change
Time frame: (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.
11 secondary outcomes
Flow mediated vasodilatation change
Time frame: (1) 0-week visit, (2) 48-week visit
Liver fibrosis change
Time frame: (1) 0-week visit, (2) 48-week visit
Liver steatosis change
Time frame: (1) 0-week visit, (2) 48-week visit
Fasting lipid change
Time frame: (1) 0-week visit, (2) 48-week visit
Neurocognitive function change
Time frame: (1) 0-week visit, (2) 24-week visit, (3) 48-week visit
Community Periodontal Index (CPI)
Time frame: (1) 0-week visit, (2) 48-week visit
beta 2-microglobulin change
Time frame: (1) 0-week visit, (2) 48-week visit
Soluble CD14 change
Time frame: (1) 0-week visit, (2) 48-week visit
ICAM-1 change
Time frame: (1) 0-week visit, (2) 48-week visit
High Sensitivity C-Reactive Protein (hsCRP) change
Time frame: (1) 0-week visit, (2) 48-week visit
Vascular Cell Adhesion Molecule-1 (V CAM-1) change
Time frame: (1) 0-week visit, (2) 48-week visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Results publication: PubMed 29067253Chastain 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.
- Derived from this study: PubMed 37772075Yunihastuti 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of CMV, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid intima medial tunica change (time frame: (1) 0-week visit, (2) 48-week visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.