AEGiS-15IAC: Availability and palatability of antiretroviral formulations appropriate for paediatric patients in Thailand.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Availability and palatability of antiretroviral formulations appropriate for paediatric patients in Thailand.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. B10133)

Kraisintu K, Eksaengsri A
Government Pharmaceutical Organization, Bangkok, Thailand

ISSUES: Thailand, an estimated 700,000 people are living with HIV/AIDS. Approximately 20,000 children aged 15 and less requiring ART. The treatment regimen for paediatric patients should mirror those of adults at all level care. This is currently difficult because of the lack of appropriate paediatric formulations. Clinical trials of ARV agents in HIV-infected children and the development of drug formulations appropriate for administration to children have often been delayed until after the development of adult formulations have been completed and/or the drug has been approved for use among infected adults. However,the paucity of paediatric specifc data cannot deter the treatment of paediatric patients.

DESCRIPTION: Government Pharmaceutical Organization (GPO), Thailand, is a state enterprise under Ministry of Public Health(MOPH). Its function is to manufacture and supply of pharmaceuticals and other medical products, to support health services activities of MOPH throughout the country. As of December 2003, there are 6 ARV drugs approved for use in paediatric patients e.g. zidovudine syrup 10 mg/ml, didanosine buffered oral powder 30 and 60 mg,stavudine for oral solution 1 mg/ml and 5 mg/ml,nevirapine oral suspension 10 mg/ml, lamivudine syrup 10 mg/ml and nelfinavir tablet 250 mg.

LESSONS LEARNED: There are unique considerations needed for AIDS paediatric patients. They include the changes in pharmacokinetic parameters with age caused by the continuing development and maturation of organ systems involved in drug metabolism and clearance. Special consideration also associated with adherence to ART.

RECOMMENDATIONS: To maximize therapeutic options for HIV-infected paediatric patients throughout the course of their infection, drug formulations should facilitate the development of palatable, easy-to-take fixed dose combination ARV drugs as treatment options for children.

Keywords: AEGIS, Anti-HIV Agents, Stavudine, Nevirapine, Thailand, Acquired Immunodeficiency Syndrome, HIV Infections, Didanosine, HIV, Zidovudine, Lamivudine, Nelfinavir, HIV Seropositivity, Clinical Trials, Adult, Humans, Child

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B10133