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

Hannah Green, Diana M. Gibb, Alexandra Compagnucci, Vania Giacomet, Anita De Rossi, Lynda Harper, Yacíne Saï, Guida Castelli-Gattinara, Deenan Pillay, Abdel G. Babiker, Jean Pierre Aboulker, Hermione Lyall, Lee T. Bacheler, A. Sarah Walker, Marianne Debré, Raffaella Rosso, David M. Burger, Marinella Della Negra, David T. Dunn, Carlo Giaquinto

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)857-867
Number of pages11
JournalAntiviral Therapy
Volume11
Issue number7
Publication statusPublished - 2006

ASJC Scopus subject areas

  • Pharmacology

Fingerprint Dive into the research topics of 'A randomized controlled trial of genotypic HIV drug resistance testing in HIV-1-infected children: The PERA (PENTA 8) Trial'. Together they form a unique fingerprint.

Cite this