Form Data Uji Klinik FKUI Tahun 2020

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Form Data Uji Klinik FKUI Tahun 2020 - 2023

Judul Uji Klinis

Nama Peneliti

Afiliasi

Judul Penelitian

Lokasi Penelitian

Sponsor

Contract Research Organization (CRO)

Bahan Uji (Obat, Alkes, OMAI, Herbal, Stem Cell, Vaksin dll)

Kolaborator

Deskripsi

Persistent immune activation and inflammation in HIV infection were linked to excess cardiovascular risk and other non-communicable diseases. Periodic asymptomatic CMV reactivity in HIV-infected patients over a lifetime might have contributed to non-AIDS defining morbidity. Despite undetectable levels of HIV and CMV, these patients continued to have increased levels of biomarkers and immune activations. Statin administration was thought to reduce subclinical atherosclerosis by decreasing LDL-C levels. It might also have added beneficial effects against CMV infection.

We conducted a double-blind, placebo-controlled trial in which patients were randomized to receive either atorvastatin or placebo with a ratio of 1:1. This trial aimed to study the effect of atorvastatin in statin-naive virally-suppressed HIV-infected patients with stable ART and CMV seropositivity on carotid intima-media thickness (CIMT), a tool that evaluates subclinical atherosclerosis. The study recruited 80 patients at the HIV integrated care unit of Cipto Mangunkusumo hospital. All eligible subjects had CIMT evaluation as the primary outcome, along with flow-mediated vasodilatation (FMD), liver fibrosis and steatosis evaluation, fasting lipid, neurocognitive test, community periodontal index (CPI), and residual immune activation as secondary outcomes over 48 weeks.

The main purpose of our study was to evaluate the effect of atorvastatin administration on CIMT changes in statin-naïve virally suppressed HIV-infected patients with stable ART and CMV seropositivity.

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