Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children (PENTA 13)
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Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.
Condition or disease
Drug: ABC Twice DailyDrug: ABC Once DailyDrug: 3TC Once DailyDrug: 3TC Twice Daily
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Ages Eligible for Study:
2 Years to 13 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children with definitive HIV infection
Age > 2 and < 13 years
Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.
• Intercurrent illness
Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
Abnormal renal or liver function (grade 3 or above)