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The Effect Of Atorvastatin On Frailty Syndrome Indicators In Human Immunodeficiency Virus Patients Receiving Antiretroviral Therapy

The Effect Of Atorvastatin On Frailty Syndrome Indicators In Human Immunodeficiency Virus Patients Receiving Antiretroviral Therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240418003
Enrollment
80
Registered
2024-04-18
Start date
2024-01-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) patients with frailty syndrome indicators (Pre-Frail/ Frail). Human immunodeficiency virus , frailty syndrome, atorvastatin

Interventions

The study intervention involves administering atorvastatin therapy at a dosage of 40 mg once daily for a duration of 12 weeks.,The study intervention involves administering amilum as a placebo compara
Experimental Drug,Placebo Comparator Other
Atorvastatin,Amilum

Sponsors

Faculty of Medicine, University of Syiah Kuala
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Has been receiving ARV therapy for 6 months or more 2. Willing to undergo all necessary examinations (physical examination, laboratory tests, and interviews) completely 3. Capable of understanding and following instructions during examinations by the Research Team effectively 4. Willing to sign the informed consent letter as research subjects.

Exclusion criteria

Exclusion criteria: 1. Patients experiencing acute illness (e.g., acute complaints like severe headache, high fever, nausea, vomiting, or other acute complaints) during selection, such as cases of urgency/emergency hypertension, acute arthritis, or stroke. 2. Patients with physical or mental disabilities affecting the data collection process, history of limb amputation, extremity paralysis, history of brain infection, cancer, or unable to walk normally without assistance. 3. Patients with a history of allergy to statin preparations. 4. Pregnant or breastfeeding patients. 5. Patients with severe kidney dysfunction: creatinine >2.0 g/dL and/or calculated creatinine clearance (CCT) <30 ml/minute. 6. Patients with liver cirrhosis or liver dysfunction (AST and ALT >3 times the upper limit of normal). 7. Patients with severe heart dysfunction: diagnosis of acute decompensated heart failure and/or chronic heart failure class III/IV (according to the New York Heart Association). 8. Patients with severe lung dysfunction: diagnosis of acute exacerbation of COPD and/or COPD or low oxygen saturation (SpO2 <90%) using pulse oximetry.

Design outcomes

Primary

MeasureTime frame
Frailty syndrome Indicator at 12 weeks after end of the intervention Cardiovascular health study (CHS) and frailty index-40 items

Secondary

MeasureTime frame
Sarcopenia state at 12 weeks after end of the intervention Bioelectrical impedance analysis (BIA) and myostatin level

Countries

Indonesia

Contacts

Public ContactMaryatun Hasan

Faculty of Medicine, Syiah Kuala University

maryatun.hasan@usk.ac.id6282211248424

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026