drugset / Trial / NCT00089583
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
Non-randomizedParallel-groupOpen-labelTreatment
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 .
Timeline
- Start
- 2004-07
- Primary completion
- 2011-03
- Completion
- 2013-07
Publications
- Background Voronin E, Fortuny C, Perez-Tamarit D, et al. Pharmacokinetics, safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2 to 18 year-old children (48-week data, Study APV29005, a prospective, open-label, multi-centre, 48-week cohort study). Presented at: AIDS 2012 - 19th International AIDS Conference; July 22-27, 2012; Washington, DC.
- Background Ross L, Cotton M, Cassim H, et al. HIV-1 drug resistance and mutational profile in fosamprenavir-treated HIV-infected children aged 2 months to 18 years at start of therapy. Presented at: AIDS 2012 - 19th International AIDS Conference; July 22-27, 2012; Washington DC.
- Results Fortuny C, Duiculescu D, Cheng K, Garges HP, Cotton M, Tamarirt DP, Ford SL, Wire MB, Givens N, Ross LL, Lou Y, Perger T, Sievers J. Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children. Pediatr Infect Dis J. 2014 Jan;33(1):50-6. doi: 10.1097/INF.0b013e3182a1126a.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosamprenavir | Small molecule | 18 mg/kg | — |
| Subject | Fosamprenavir | Small molecule | 23 mg/kg | — |
| Subject | Fosamprenavir | Small molecule | 30 mg/kg | — |
| Subject | Fosamprenavir | Small molecule | 700 mg | — |
| Subject | Ritonavir | Other / unclassified | 3 mg/kg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |