1. A randomized controlled trial of genotypic HIV drug resistance testing in HIV-1-infected children: the PERA (PENTA 8) trial.
- Author
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Green H, Gibb DM, Compagnucci A, Giacomet V, de Rossi A, Harper L, Saïdi Y, Castelli-Gattinara G, Pillay D, Babiker AG, Aboulker JP, Lyall H, Bacheler LT, Walker AS, Debré M, Rosso R, Burger DM, Della Negra M, Dunn DT, and Giaquinto C
- Subjects
- Adolescent, Brazil, Child, Child, Preschool, Drug Resistance, Viral, Europe, Female, HIV Infections virology, HIV-1 genetics, Humans, Infant, Male, Species Specificity, Treatment Outcome, Anti-Retroviral Agents pharmacology, Anti-Retroviral Agents therapeutic use, HIV Infections drug therapy, HIV-1 drug effects
- Abstract
Objective: To evaluate the longer-term utility of genotypic resistance testing in HIV-1-infected children with virological failure., Methods: Children aged 3 months-18 years switching antiretroviral therapy (ART) with HIV-1 RNA > 2,000 copies/ml were randomized between genotypic testing (Virtual Phenotype) and no testing at baseline and subsequent virological failures. Children were followed to at least 96 weeks., Results: One hundred and seventy eligible children, from 24 clinical centres in six countries, were randomized to resistance testing (n = 87) or no testing (n = 83) between June 2000-July 2003. At baseline, mean HIV-1 RNA and CD4+ T-cell percentage were 4.7 log10 copies/ml and 20%, respectively. Children had taken ART for a mean of 5 years; 24% had received all three classes, 53% nucleoside reverse transcriptase inhibitors (NRTIs)+protease inhibitors (PIs), 9% NRTIs+non-nucleoside reverse transcriptase inhibitors (NNRTIs) and 14% NRTIs only. There was no difference between the arms in the drug classes or the individual PIs/NNRTIs prescribed. However, 49% in the resistance test arm (RT) versus 19% in the no-test arm (NT) continued at least one NRTI from their failing regimen; 56% versus 19% were prescribed didanosine+stavudine as their NRTI backbone. Adjusting for baseline HIV-1 RNA, mean reductions in HIV-1 RNA at 48 weeks were 1.51 log10 copies/ml in the RT arm and 1.23 in the NT arm (P = 0.3); the difference between the arms was smaller at week 96 (RT: 1.50, NT: 1.47; P = 0.9)., Conclusion: In this first paediatric trial of resistance testing, we observed a substantial difference in NRTI-prescribing behaviour across arms. However statistically significant evidence of a long-term virological or immunological benefit was not observed. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN14367816.
- Published
- 2006