A randomized controlled trial of genotypic HIV drug resistance testing in HIV-1-infected children: the PERA (PENTA 8) trial.

Green, H; Gibb, D; Compagnucci, A; Giacomet, V; de Rossi, A; Harper, L; Saïdi, Y; Castelli-Gattinara, G; Pillay, D; Babiker, A; Aboulker, J; Lyall, H; Bacheler, LT; Walker, A; Debré, M; Rosso, R; Burger, D; Della Negra, M; Dunn, D; Giaquinto, C

Journal article

A randomized controlled trial of genotypic HIV drug resistance testing in HIV-1-infected children: the PERA (PENTA 8) trial.

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.

Publication status:: Published

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APA Style

Green, H., Gibb, D., Compagnucci, A., Giacomet, V., de Rossi, A., Harper, L., Saïdi, Y., Castelli-Gattinara, G., Pillay, D., Babiker, A., Aboulker, J., Lyall, H., Bacheler, L. T., Walker, A., Debré, M., Rosso, R., Burger, D., Della Negra, M., Dunn, D., & Giaquinto, C. (2006). A randomized controlled trial of genotypic HIV drug resistance testing in HIV-1-infected children: the PERA (PENTA 8) trial. Antiviral Therapy, 11(7), 857–867.

MLA Style

Green, H., et al. “A Randomized Controlled Trial of Genotypic HIV Drug Resistance Testing in HIV-1-Infected Children: the PERA (PENTA 8) Trial.” Antiviral Therapy, vol. 11, no. 7, 2006, pp. 857–67.

Chicago Style

Green, H, D Gibb, A Compagnucci, V Giacomet, A de Rossi, L Harper, Y Saïdi, et al. 2006. “A Randomized Controlled Trial of Genotypic HIV Drug Resistance Testing in HIV-1-Infected Children: the PERA (PENTA 8) Trial.” Antiviral Therapy 11 (7): 857–67.
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