Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
Summary
Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
Timeline
- Start
- 2002-08
- Primary completion
- 2009-08
- Completion
- 2010-03
Outcome
Missed primary endpoint
registry analysis (unspecified test); Drug Class/PI vs Drug Class/NNRTI; p = 0.26; Mean Difference (Final Values) -0.15 (95% CI -0.41 to 0.11); Interval regression NCT00039741 ↗
registry analysis (unspecified test); Switch Point (1K) vs Switch Point (30K); p = 0.56; Mean Difference (Final Values) 0.06 (95% CI -0.20 to 0.32); Interval regression NCT00039741 ↗
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 Havens PL. Principles of antiretroviral treatment of children and adolescents with human immunodeficiency virus infection. Semin Pediatr Infect Dis. 2003 Oct;14(4):269-85. doi: 10.1053/j.spid.2003.09.005.
- Background Hoody DW, Fletcher CV. Pharmacology considerations for antiretroviral therapy in human immunodeficiency virus (HIV)-infected children. Semin Pediatr Infect Dis. 2003 Oct;14(4):286-94. doi: 10.1053/j.spid.2003.09.004.
- Background McKinney RE Jr, Cunningham CK. Newer treatments for HIV in children. Curr Opin Pediatr. 2004 Feb;16(1):76-9. doi: 10.1097/00008480-200402000-00014.
- Results PENPACT-1 (PENTA 9/PACTG 390) Study Team; Babiker A, Castro nee Green H, Compagnucci A, Fiscus S, Giaquinto C, Gibb DM, Harper L, Harrison L, Hughes M, McKinney R, Melvin A, Mofenson L, Saidi Y, Smith ME, Tudor-Williams G, Walker AS. First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: an open-label, randomised phase 2/3 trial. Lancet Infect Dis. 2011 Apr;11(4):273-83. doi: 10.1016/S1473-3099(10)70313-3. Epub 2011 Jan 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | — | — |
| Subject | Amprenavir | Other / unclassified | — | — |
| Subject | Efavirenz | Other / unclassified | — | — |
| Subject | INDINAVIR ANHYDROUS | Other / unclassified | — | — |
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Nelfinavir | Other / unclassified | — | — |
| Subject | Nevirapine | Small molecule | — | — |
| Subject | Ritonavir | Other / unclassified | — | — |
| Subject | Saquinavir | Small molecule | — | — |
| Subject | Stavudine | Other / unclassified | — | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Subject | Zalcitabine | Small molecule | — | — |
| Subject | Zidovudine | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |
| Subject | emtricitabine/Tenofovir disoproxil fumarate | Unknown | — | — |
| Subject | lamivudine/zidovudine | Unknown | — | — |
| Subject | lopinavir/ritonavir | Unknown | — | — |