ผลงานวิจัย

หมายเลขหนังสือ3
ชื่องานวิจัยA Preliminary Results of the Safety and Efficacy of a Cytokine Inhibitor : Vesnarinone in Asymptomatic HIV-1 Infected Thai with Greater than 200 CD4+ Cells/MM^3
ชื่อผู้แต่งKiat Ruxrungtham
สถาบันChulalongkorn Universtiy
ที่มาRuxrungtham K., Tirawatanapong S., Ubolyam S., Suthapinthu P., Kashiwaki N., Adachi M. and Phanuphak P.
คำสำคัญtherapy, clinical, asymptomatic
ปี พ.ศ.2538
จำนวนหน้า0
ประเภทเอกสารบทคัดย่อ
บทคัดย่อBackground : There are evidences of TNF-alpha and IL-6 upregulation of HIV-1 replication. Vesnarinone is a new inotropic agent but is found recently that has inhibitory effect on TNF-alpha and IL-6 production as well as anti-HIV activity. The clinical benefit of this agent required further investigation. Objective : To evaluate the safety and efficacy of vesnarinone, 60 mg oral daily in asymptomatic HIV-infected individuals with >200 CD4+ cells/cu.mm. Methods : An Open trial, 20 asymptomatic HIV-infected individuals were enrolled according to study criteria with informed consent. Each was then received 60 mg oral daily of Vesnarinone for 24 weeks. Clinical safety (toxicity) and disease progression to AIDS are the primary outcomes. Blood samples were collected at week -2, 0, 2, 4, 8, 12, 16, 20 and 24 for CBC, Chemistry, CD4 cell count, Cytokine (TNF-alpha and IL-6) analysis, P24 Ag assay. HIV-1 serosubtyping and plasma concentration of vesnarinone. Using State Veiw TM SE+ Graphics and Paired student t-test for data analysis. Results : 25 cases were enrolled, 5 were dropped out and 12 cases and completed the 24 weeks study. They are 11 males and 9 females, age 29.7+6.6 (21.43). Risk : 16 hetero, 4 homo and 2 bisexuals. HIV-1 subtyping revealed that (n=16) : 13 subtype E, I BMN and 2 nontypable. There were 8 and 4 reported cases of increasing appetite and sedative effect, respectively, but was no leukopenia observed. At 12 and 24 weeks anaysis : Change in body weight (BW) was increased significantly (p=0.05 and <0.05 respecitvely) as well as the CD4 cell counts were also increased (p<0.05 and <0.01, respectively). The % of monocytes expressing intracytoplasmic. TNF-alpha was significantly declined only at 12 weeks of study. The plasma concentrations of Vesnarinone were 4.9+1.5 microgram/ml. Conclusions : Our prelininary analysis demonstrated that vesnarinone (60 mg/day) is a promising agent and might be beneficial in term of increasing BW and CD4 cell counts. The modest effect on anti. TNF-alpha was also observed. The viral load analysis both cellular and plasma viremia are being performed. A double-blined placebo control study as well as a dose-reponse trial are needed to confirm these positive findings and to identify the optimal effective regimen.
 
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