Penta HIV Trials | PENTA 9

HIV-1 Drug Resistance and Second-line Treatment in Children Randomized to Switch at Low versus Higher RNA Thresholds

2015

Authors: Harrison L, Melvin A, Fiscus S, et al. For PENPACT-1 (PENTA 9PACTG 390) Study Team.

Published in: JAIDS 2015;70(1):42-53

Background The 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.

Methods PENPACT-1 had a 2 × 2 factorial design,

Using CD4 Percentage and Age to Optimize Pediatric Antiretroviral Therapy Initiation

2014

Authors: Yin D., Warshaw M., Miller W., Castro H., Fiscus S., Harper L., Harrison L., Klein N., Lewis J., Melvin A., Tudor-Williams G., McKinney R.

Published in: Pediatrics, 2014;134(4):e1104-16

Background Quantifying pediatric immunologic recovery by highly active antiretroviral therapy (HAART) initiation at different CD4 percentage (CD4%) and age thresholds may inform decisions about timing of treatment initiation.

HIV-1 resistance after randomized virologic switch at 1,000 or 30,000 c/ml in children.

2014

Authors: Harrison L, Gibb DM, Fiscus S, Saïdi Y, Nastouli E, Harper L, Compagnucci A, Babiker A, Melvin A, Tudor-Williams G and the PENPACT 1 (PENTA 9/PACTG 390) Study Team.

Published in: CROI 2014, 3-6 March 2014, Boston. Poster 898.

First-line antiretroviral therapy initiation with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor combination and switch at higher versus low viral load in HIV-infected children: an open randomised controlled phase 2/3 trial.

2011

Authors: The PENPACT-1 (PENTA 9 / PACTG 390) Study Team.

Published in: Lancet Infectious Diseases. April: 2011, 273-283

Background Children with HIV will be on antiretroviral therapy (ART) longer than adults, and therefore the durability of first-line ART and timing of switch to second-line are key questions. We assess the long-term outcome of protease inhibitor and non-nucleoside reverse transcriptase inhibitor (NNRTI) first-line ART and viral load switch criteria in children.

PENTA and IMPAACT: A phase II/III randomised, open-label trial of combination antiretroviral regimens and treatment-switching strategies in HIV-1-infected antiretroviral naïve children

2010

PENTA and IMPAACT: A phase II/III randomised, open-label trial of combination antiretroviral regimens and treatment-switching strategies in HIV-1-infected antiretroviral naïve children

Published in: XVIII International AIDS Conference, 22nd July 2010, Vienna Austria.

Choice of first-line ART regimen in PENPACT 1: a randomized trial of combination antiretroviral regimens and treatment switching strategies in antiretroviral naive children >30 days and <18 years of age.

2004

Authors: Gibb DM, Melvin A, Compagnucci A, McKinney R, Tudor-Williams G, Walker AS, Harper L, Hodge J, Powell C, Green H, Saïdi Y, Ortiz AA, Toye M, Girard S, Mofenson L, Giaquinto C, Hughes M on behalf of the PENPACT 1 Trial.

Published in: XV International AIDS Conference, 11-16 July 2004, Bangkok. Poster TuPeB4442.

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