Trial reportJournal of acquired immune deficiency syndromes (1999)2015
HIV-1 Drug Resistance and Second-Line Treatment in Children Randomized to Switch at Low Versus Higher RNA Thresholds.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Trial
- HIV-1 Drug Resistance in Children and Implications for Pediatric Treatment Strategies: A Systematic Review and Meta-analysis.Open forum infectious diseases · 2025Review
- HIV drug resistance, early treatment outcomes and impact of guidelines compliance after protease inhibitor-based second-line failure in a dedicated resistance clinic in western Kenya: a retrospective cohort study.Journal of the International AIDS Society · 2025Article
- A Per-Protocol Analysis Using Inverse-Probability-of-Censoring Weights in a Randomized Trial of Initial Protease Inhibitor Versus Nonnucleoside Reverse Transcriptase Inhibitor Regimens in Children.American journal of epidemiology · 2023Article
- Incidence of switching to second-line antiretroviral therapy and associated factors in children with HIV: an international cohort collaboration.The lancet. HIV · 2019Article
- Time to First-Line ART Failure and Time to Second-Line ART Switch in the IeDEA Pediatric Cohort.Journal of acquired immune deficiency syndromes (1999) · 2018Article
- Time to Switch to Second-line Antiretroviral Therapy in Children With Human Immunodeficiency Virus in Europe and Thailand.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Observational
- Impact of Human Immunodeficiency Virus Drug Resistance on Treatment of Human Immunodeficiency Virus Infection in Children in Low- and Middle-Income Countries.The Journal of infectious diseases · 2017Article
- Observational
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundThe PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold.
methodsPENPACT-1 had a 2 × 2 factorial design, randomizing HIV-infected children to start protease inhibitor (PI) versus nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, and switch at a 1000 copies/mL versus 30,000 copies/mL threshold. Switch criteria were not achieving the threshold by week 24, confirmed rebound above the threshold thereafter, or Center for Disease Control and Prevention stage C event. Resistance tests were performed on samples ≥1000 copies/mL before switch, resuppression, and at 4-years/trial end.
resultsSixty-seven children started PI-based ART and were randomized to switch at 1000 copies/mL (PI-1000), 64 PIs and 30,000 copies/mL (PI-30,000), 67 NNRTIs and 1000 copies/mL (NNRTI-1000), and 65 NNRTI and 30,000 copies/mL (NNRTI-30,000). Ninety-four (36%) children reached the 1000 copies/mL switch criteria during 5-year follow-up. In 30,000 copies/mL threshold arms, median time from 1000 to 30,000 copies/mL switch criteria was 58 (PI) versus 80 (NNRTI) weeks (P = 0.81). In NNRTI-30,000, more nucleoside reverse transcriptase inhibitor (NRTI) resistance mutations accumulated than other groups. NNRTI mutations were selected before switching at 1000 copies/mL (23% NNRTI-1000, 27% NNRTI-30,000). Sixty-two children started abacavir + lamivudine, 166 lamivudine + zidovudine or stavudine, and 35 other NRTIs. The abacavir + lamivudine group acquired fewest NRTI mutations. Of 60 switched to second-line, 79% PI-1000, 63% PI-30,000, 64% NNRTI-1000, and 100% NNRTI-30,000 were <400 copies/mL 24 weeks later.
conclusionsChildren on first-line NNRTI-based ART who were randomized to switch at a higher virologic threshold developed the most resistance, yet resuppressed on second-line. An abacavir + lamivudine NRTI combination seemed protective against development of NRTI resistance.
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