drugset / Trial / NCT00260078
Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children
Phase 1/2
Completed
75 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.
Timeline
- Start
- 2006-02
- Primary completion
- 2009-04
- Completion
- 2009-04
Publications
- Background Kiser JJ, Fletcher CV, Flynn PM, Cunningham CK, Wilson CM, Kapogiannis BG, Major-Wilson H, Viani RM, Liu NX, Muenz LR, Harris DR, Havens PL; Adolescent Trials Network for HIV/AIDS Interventions. Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection. Antimicrob Agents Chemother. 2008 Feb;52(2):631-7. doi: 10.1128/AAC.00761-07. Epub 2007 Nov 19.
- Background Hazra R, Gafni RI, Maldarelli F, Balis FM, Tullio AN, DeCarlo E, Worrell CJ, Steinberg SM, Flaherty J, Yale K, Kearney BP, Zeichner SL. Tenofovir disoproxil fumarate and an optimized background regimen of antiretroviral agents as salvage therapy for pediatric HIV infection. Pediatrics. 2005 Dec;116(6):e846-54. doi: 10.1542/peds.2005-0975. Epub 2005 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 200 mg | Oral |
| Subject | Atazanavir | Other / unclassified | 400 mg | Oral |
| Subject | Darunavir | Small molecule | 300 mg | Oral |
| Subject | Darunavir | Small molecule | 600 mg | Oral |
| Subject | Efavirenz | Other / unclassified | — | — |
| Subject | Nevirapine | Small molecule | — | — |
| Subject | Ritonavir | Other / unclassified | 50 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |