Conditions: Infection, Human Immunodeficiency Virus I
Keywords: antiretroviral therapy pediatrics AGENERASE amprenavir fosamprenavir HIV Infection ritonavir protease inhibitor LEXIVA
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: no

Brief summary:
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .

Detailed description:
A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of GW433908/Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18 years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to \<6 years old

Arms:
arm 1: Cohort 1B - 2 - less than 6yrs old (FPV/RTV BID) Cohort 2 - 6 to less than 12 yrs old (FPV/RTV BID) Cohort 3 - 12 - 18 yrs old (FPV/RTV BID) Cohort 4 - 2 - 18 yrs (FPV/RTV BID) arm 2: Cohort 1A - 2 - less than 6yrs old (FPV BID)

Interventions: intervention 1: LEXIVA (GW433908) intervention 2: Ritonavir
Intervention descriptions: intervention 1: Fosamprenavir suspension or tablet bid intervention 2: Ritonavir solution bid

Protocol document: