drugset / Trial / NCT00102206
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
Phase 2
Completed
6 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2007-05
Publications
- Background Brogly S, Williams P, Seage GR 3rd, Oleske JM, Van Dyke R, McIntosh K; PACTG 219C Team. Antiretroviral treatment in pediatric HIV infection in the United States: from clinical trials to clinical practice. JAMA. 2005 May 11;293(18):2213-20. doi: 10.1001/jama.293.18.2213.
- Background Gavin PJ, Yogev R. The role of protease inhibitor therapy in children with HIV infection. Paediatr Drugs. 2002;4(9):581-607. doi: 10.2165/00128072-200204090-00004.
- Background Handforth J, Sharland M. Triple nucleoside reverse transcriptase inhibitor therapy in children. Paediatr Drugs. 2004;6(3):147-59. doi: 10.2165/00148581-200406030-00002.
- Background Neely M, Kovacs A. Management of Antiretroviral Therapy in Neonates, Children, and Adolescents. Curr Infect Dis Rep. 2003 Dec;5(6):521-530. doi: 10.1007/s11908-003-0097-4.
- Background Piketty C, Race E, Castiel P, Belec L, Peytavin G, Si-Mohamed A, Gonzalez-Canali G, Weiss L, Clavel F, Kazatchkine MD. Efficacy of a five-drug combination including ritonavir, saquinavir and efavirenz in patients who failed on a conventional triple-drug regimen: phenotypic resistance to protease inhibitors predicts outcome of therapy. AIDS. 1999 Jul 30;13(11):F71-7. doi: 10.1097/00002030-199907300-00001.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | — | — |
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Lopinavir/ritonavir | Unknown | — | — |
| Subject | Saquinavir | Small molecule | — | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Subject | Zidovudine | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |