To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children. To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI naïve HIV-1 infected Thai children
In 2002, the Thai Ministry of Public Health (MOPH) launched the National Access to Antiretroviral Program for People living with HIV/AIDS (NAPHA) with the aim of providing treatment to all Thai patients who needed antiretroviral treatment. By the end of 2005, 80,000 HIV-infected Thais were treated in the NAPHA program, including about 6,000 children. The antiretroviral treatment regimen consists of three antiretroviral drugs (ARV). The first-line regimen used in NAPHA are mainly generic drugs produced by Thai government pharmaceutical organization (GPO), including a fixed-drug combination of stavudine, lamivudine, and nevirapine (GPOvir);and a fixed-drug combination of zidovudine, lamivudine, and nevirapine (GPOvir-Z). Majority of patients respond very well with first-line regimen(1,2), however about 15% of patients have drug resistance to first-line regimen and require second-line regimen(3). The protease inhibitors (PIs) is used as a second-line regimen, however there are limitations in terms of cost and metabolic complications(4). Lopinavir/ritonavir is the most widely use protease inhibitors in children because of its high efficacy and a syrup formulation that easy to use in small children. There is evidence supported that the recommended dose according to US-FDA or EU guidelines resulting in much higher plasma blood level in Thai children. Data from 19 Thai children demonstrated Cmin of 5.9 mg/L compare to 3.4 mg/L in US children when use the same dose (the minimum acceptable Cmin is 1.0 mg/L) (5,6). There is a study HIVNAT019, which demonstrated acceptable LPV plasma concentration and treatment outcome in Thai HIV-infected adult when use reduced dose of LPV/r 266mg/66 mg compare to standard dose of 400mg/100mg (7). Therefore, the study of pharmacokinetic of low dose of LPV/r in Thai HIV-infected children is very important to assess the safety and efficacy of this strategy. This will lead to appropriate ARV dose in children to reduce long-term adverse events, and also reduce the ARV cost.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
* BW 6-7.9 kg: 1.5 mL oral q 12 hr * BW 8.0-16.9 kg: 2.0 ml oral q 12 hr * BW 17.0-19.9 kg: 2.5 ml oral q 12 hr * BW 20.0 - 24.9 kg: 3.0 ml oral q 12 hr * BW 25.0 - 29.9 kg: 3.5 ml oral q 12 hr * BW 30.0-34.9 kg: 4.0 ml oral q 12 hr * BW \> 35 kg: 5.0 ml oral q 12 hr Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)
* BW 6-7.9 kg: 1.0 mL oral q 12 hr * BW 8.0-16.9 kg: 1.5 ml oral q 12 hr * BW 17.0-19.9 kg: 1.8 ml oral q 12 hr * BW 20.0 - 24.9 kg: 2.0 ml oral q 12 hr * BW 25.0 - 29.9 kg: 2.5 ml oral q 12 hr * BW 30.0-34.9 kg: 3.0 ml oral q 12 hr * BW \> 35 kg: 3.5 ml oral q 12 h Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)
HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok
Bangkok, Thailand
pharmacokinetics of standard vs low dose LPV/r
Time frame: 4 weeks after start ART
efficacy and safety of standard and low dose LPV/r
Time frame: 48 weeks
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