HIV Infections Clinical Trial
Official title:
Pharmacokinetics and Efficacy of Low- or Standard-dose of Lopinavir/Ritonavir (Kaletra®) in PI-naïve HIV-1 Infected Children
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.
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