Publications

Neurocognitive and Quality of Life Outcomes in Children after Planned Treatment Interruptions: the randomized PENTA 11 trial.

2012

Authors: Ramos J., Melvin D, Medin G, Compagnucci A, Bleier J, Boscolo V, Barclay L, Ory S, Giaquinto C, Gibb D. on behalf of the PENTA Steering Committee.

Published in: 19th Conference on Retroviruses and Opportunistic Infections, San Francisco, 5-8 March 2012, Poster

Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. Update 2011

2012

Authors: Antinori A., Marcotullio S., Ammassari A., Andreoni M., Angarano G., Armignacco O., Carosi G., Cinque P., d’Arminio Monforte A., Di Perri G., Ensoli B., Florida M., Galli M., Mastroianni C., Matteelli A., Mazzotta F., Moroni M., Pal G., Puoti M., Puro V., Rizzardini G., Sagnelli E., Vella S., Vullo V., Lazzarin A., Italian HIV Guidelines Working Group (Giaquinto C.  member of Study Group)

Published inNew Microbiol 2012,

Phylodynamic and Phylogeographic Patterns of the HIV-1 Subtype F1 Parenteral Epidemic in Romania.

2012

Authors: Mbisa JL, Hue S, Buckton AJ, et al.

Published in: AIDS Res Hum Retroviruses. 2012;28(9):1161-1166

Abstract In the late 1980s an HIV-1 epidemic emerged in Romania that was dominated by subtype F1. The main route of infection is believed to be parenteral transmission in children. We sequenced partial pol coding regions of 70 subtype F1 samples from children and adolescents from the PENTA-EPPICC network of which 67 were from Romania.

Pharmacokinetics of 100/25 mg lopinavir/ritonavir tablets in children when dosed twice daily according to FDA weightbands.

2012

Authors: D Bastiaans, S. Forcat, H.E.G. Lyall, T.R. Cressey, S. Chalermpantmetagul, Y. Saïdi, H.J. Scherpbier, A. Warris, A. Compagnucci, C. Giaquinto, E.P. Colbers, D.M. Burger on behalf of PENTA KONCERT Study Group.

Published in: 6th Netherlands Conference on HIV Pathogenesis, Prevention and Treatment. November 27, 2012. 

Antiretroviral use in Italian children with perinatal HIV infection over a 14 – year period

2012

Authors:  Chiappini E., Galli L., Tovo P.A., Gabiano C., Lisi C., Giacomet V., Bernardi S., Esposito S., Rosso R., Giaquinto C ., Badolato R., Guarino A., Maccabruni A., Masi M., Cellini M., Salvini F., Di Bari C., Dedoni M., Dodi I., De Martino M for the Italian Register for HIV infection in children

Published in: Acta Paediatr, 2012, 101: 287-295

Background:  Information on the use of new antiretroviral drugs in children in the real setting of clinical fields is largely unknown.

Body Fat Abnormality in HIV-infected children and adoloscents living in Europe: prevalence and risk factors

2012

Authors: Alam N., Cortina – Borja M., Goetghebuer T., et al. European Paediatr HIV & Lipodystrop (Giaquinto C.  member of the Study Group)

Published in: JAIDS, 2012, 59: 314 – 32

Objectives: To estimate the prevalence of and identify risk factors for lipodystrophy syndrome (LS) and body fat abnormality in a population of HIV-infected children and adolescents.

Short and long term immunological and virological outcome in HIV-infected infants according to the age at antiretroviral treatment initiation. 

2012

Authors: Goetghebuer T, Le Chenadec J, Haelterman E, et al.

Published in: Clinical Infectious Diseases 2012; 54(6): 878-881

Abstract The clinical benefit of antiretroviral therapy in infants is established. In this cohort collaboration, we compare immunological and virological response to treatment started before or after 3 months of age. Early initiation provides a better short-term response,

Age and CD4 Count at Initiation of Antiretroviral Therapy in HIV-InfectedChildren: Effects on Long-term T-Cell Reconstitution

2011

Authors: Lewis J, Walker AS, Castro H, et al.

Published in: J Infect Dis. 2011;205(4):548-556

Background Effective therapies and reduced AIDS-related morbidity and mortality have shifted the focus in pediatric human immunodeficiency virus (HIV) from minimizing short-term disease progression to maintaining optimal long-term health. We describe the effects of children’s age and pre-antiretroviral therapy (ART) CD4 count on long-term CD4 T-cell reconstitution.

Early antiretroviral therapy in HIV-1 infected infants, 1996-2008: treatment response and duration of first-line regimens

2011

Authors: The European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord.

Published in: AIDS 2011; 25(18): 2279-2287

Background Durable and tolerable first-line antiretroviral therapy (ART) regimens are needed for HIV-infected infants who may need life-long treatment. We investigated virological and immunological response to ART, and predictors of switching and interrupting treatment among infants starting ART in the European Pregnancy and Paediatric HIV Cohort Collaboration.

A comparison of the pharmacokinetics of raltegravir during pregnancy and post-partum

2011

Authors: Colbers A, Taylor G, Moltó J, Ivanovic J, Taylor G, Branco T, Wyen C, van der Ende I, Gomes da Silva H, Burger D; on behalf of the PANNA network

Published: 12th International Workshop on Clinical Pharmacology of HIV Therapy, 2011 April 13th-15th, Miami. P_18

 

Long Term consequences of planned treatment interruptions in HIV infected children: Results from the TICCH (Treatment Interruption in Children with Chronic HIV-Infection )/PENTA 11 trial.

2011

Authors: Compagnucci A. on behalf of the PENTA Steering Committee

Published in: 3rd HIV Paediatric Workshop Rome 15-16 July 2011.

Effect of transmitted drug resistance on virological and immunological response to initial combination antiretroviral therapy for HIV (EuroCoord-CHAIN joint project): a European multi-cohort study.

2011

Authors: Wittkop L, Günthard HF, de Wolf F, et al. EuroCoord-CHAIN study group.

Published in: Lancet Infectious Diseases 2011; 11(5): 363-71

Background The effect of transmitted drug resistance (TDR) on first-line combination antiretroviral therapy (cART) for HIV-1 needs further study to inform choice of optimum drug regimens. We investigated the effect of TDR on outcome in the first year of cART within a large European collaboration.

Risk of triple-class virological failure in children with HIV: a retrospective cohort study

2011

Authors: Castro H, Judd A, Gibb DM, et al. Pursuing Later Treatment Options II (PLATO II) project team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE).

Published in: Lancet 2011; 377(9777): 1580-1587

Background: In adults with HIV treated with antiretroviral drug regimens from within the three original drug classes (nucleoside or nucleotide reverse transcriptase inhibitors [NRTIs],

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.

Discordance between CD4 cell count and CD4 cell percentage: implications for when to start antiretroviral therapy in HIV-1 infected children. concise Communication.

2010

Authors: HIV Paediatric Prognostic Markers Collaborative Study

Published in: AIDS 2010, 24, 1213–1217

Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.

2010

Authors: Paediatric European Network for Treatment of AIDS (PENTA)

Published in: Antivir Ther. 2010;15(3):297-305.

Background Once-daily dosing of abacavir and lamivudine has been approved for adults, but paediatric data are insufficient. We conducted a pharmacokinetic study of once-daily and twice-daily abacavir and lamivudine in children aged 3-<36 months.

Methods Children with stable HIV type-1 (HIV-1) RNA levels after 12 weeks treatment with twice-daily abacavir (8 mg/kg) with or without lamivudine (4 mg/kg) underwent plasma pharmacokinetic sampling.

A Model-based approach to dose selection in early pediatric development

2010

Authors: Cella M, Gorter de Vries F, Burger D, Danhof M, Della Pasqua O.

Published in: Clinical Pharmacology and Therapeutics, 2010, 87(3):294-302.

Abstract The establishment of a rationale for determining dosing regimens in pediatric patients remains a challenge in drug development. In this investigation, we explored several methodologies to support bridging studies and evaluated the best descriptor of developmental changes that can be used as a covariate for dose adjustment in children.

Immunologic and viral dynamics among HIV-infected children after planned treatment interruption: a substudy of the Paediatric European Network for Treatment of AIDS (PENTA) 11 trial.

2010

Authors: Sefe D, Klein N, Mosconi I, Ricci E, Castro, H (nee Green), Jacobsen M, Bernardi S, Pillay D, Gibb DM, and De Rossi A, on behalf of the PENTA Steering Committee

Published in: 17th Conference on Retroviruses and Opportunistic Infections, San Francisco, 16-19 February 2010, Poster

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.

Triple-class virologic failure in HIV-infected patients undergoing antiretroviral therapy for up to 10 years

2010

Authors: Lodwick R, Costagliola D, Reiss P, et al. Pursuing Later Treatment Options II (PLATO II) Project Team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE).

Published in: Archives of Internal Medicine. 2010; 170(5):410-419

Background: Life expectancy in people with HIV is now estimated to approach that in the general population in some successfully treated subgroups.

Response to Planned Treatment Interruptions in HIV-infection varies across Childhood in the PENTA 11 Trial

2010

Authors: Paediatric European Network for Treatment of AIDS.

Published in: AIDS. 2010;24(2):231-241.

Objective To evaluate clinical, immunological and virological consequences of CD4-guided antiretroviral therapy (ART) planned treatment interruptions (PTIs) compared with continuous therapy in children with chronic HIV infection in the Paediatric European Network for Treatment of AIDS 11 trial.

Design This was a multicentre,

PENTA 15: plasma pharmacokinetic study of once versus twice daily abacavir and lamivudine as part of combination antiretroviral therapy in HIV-1 infected children aged 3 to <36 months.

2009

Authors: Jacqz-Aigrain, Farrelly L, Compagnucci A, Harrison L, Zhao W, Hamadache D, Welch S, Wintergerst U, Firtion G, Burger D

Published in: CROI 2009. February 8-11, 2009. Palais des Congres de Montreal, Canada , Poster S-154.

PENTA 15: Once-daily abacavir and lamivudine as part of combination antiretroviral therapy to 48 weeks in HIV-1 infected children aged 3 to 36 months.

2009

Authors: Zhao W, Farrelly L, Compagnucci A, Harrison L, Jacqz-Aigrain E, Hamadache D, Welch S, Wintergerst U, Burger D on behalf of the PENTA Trial Steering Committee .

Published in: 1st International Workshop on HIV Pediatrics, 17 – 18 July 2009, Cape Town, South Africa

Adherence to ART and acceptability of planned treatment interruptions (PTI) in the PENTA 11 trial

2009

Authors: Harrison L, Hamadache D, Bunupuradah T, Mazza A, Ramos Amador JT, Flynn J, Rampon O, Mellado Pena MJ, Floret D, Marczynska M, Puga A, Farrelly L, Riault Y, Lallemant M, Compagnucci A on behalf of the PENTA Trial Steering Committee.

Published in: 1st International Workshop on HIV Pediatrics, 17 – 18 July 2009, Cape Town, South Africa. (Poster P_90).

Effect of early antiretroviral therapy on the risk of AIDS/death in HIV infected infants: the European Infant Collaborative Study.

2009

Authors: Goetghebuer T, Haelterman E, Le Chenadec J, et al. for the European infant collaboration group.

Published in: AIDS 2009;23:597-604

Objective: In the absence of treatment, rapid progression to AIDS occurs in approximately 20% of HIV-1-infected infants over the first year of life. The prognosis of these children has considerably improved with highly active antiretroviral therapy. As data from well resourced countries are lacking,

Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants.

2009

Authors: Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, Green H, Galli L, Ramos JT, Giaquinto C, Warszawski J, Levy J; for the European Infant Collaboration group.

Published in:  AIDS 2009 Feb

Treatment interruption in children with chronic HIV-infection: the results of the paediatric European network for treatment of AIDS (PENTA) 11 trial.

2008

Authors: Gibb DM, Compagnucci A, Green H, Lallemant M, et al.

Published in: Journal of the International AIDS Society 2008, 11(Suppl 1):O21 (10 November 2008)

Plasma drug concentrations and virologic evaluations after stopping non-nucleoside reverse transcriptase inhibitors (NNRTIs) in HIV-1 infected children

2008

Authors: Cressey TR, Green H, Khoo S, Treluyer J-M, Compagnucci A, Saidi Y, Lallement M, Gibb DM, Burger D.

Published in: Clin Infect Dis 2008. 15;46(10):1601-8 

Background The optimum strategy for stopping treatment with drugs that have different half-lives in a combination regimen to minimize the risk of selecting drug-resistant viruses remains unknown. We evaluated drug concentrations in plasma,

A comparison of the rate of clinical disease progression in HIV-infected children and adults allowing for current CD4 cell count.

2008

Authors: Dunn DT, Woodburn P, Duong T, Phillips AN, Gibb D, Porter K on behalf of HIV Paediatric Prognostic Markers Collaborative Study (HPPMCS) and the CASCADE Collaboration.

Published in: J Infect Dis 2008, 197:398-404

Marginal zone memory B-cell populations are irreversibly depleted in paediatric HIV infection.

2008

Authors: Jacobsen MC, Thiebaut R, Fisher C, Sefe D, Clapson M, Klein NJ, Baxendale HE.

Published in: 5th Conference on Retroviruses and Opportunistic Infections, Boston, 2- 8 February 2008, Poster A-152 /453

Markers for predicting mortality in untreated HIV-infected children in resource-limited settings: a meta-analysis

2008

Authors: Cross Continents Collaboration for Kids (3Cs4kids) Analysis and Writing Committee

Published in: AIDS. 2008 Jan 2;22(1):97-105.

Early versus deferred highly active antiretroviral therapy in HIV infected infants: a European Collaborative Cohort Study.

2007

Authors: Goetghebuer T for the European Infant Collaborative Study.

Published in: 4th Dominique Dormont International Conference, 13-15 December, 2007

Increasing Antiretroviral Drug Access for Children With HIV Infection.

2007

Published in: American Academy of Pediatrics, 2007; 119: 838-845

Treatment interruption in children with HIV infection.

2007

Authors: Green H and Gibb DM.

Published in: Curr Opin HIV AIDS 2007; 2:62-68.

Does Early Treatment Provide Long Term Benefit in HIV-1 Infected Infants? Five Year Outcomes in Children Treated Before 3 Months of Age in the PENTA 7 Trial.

2007

Authors: Compagnucci A, Saïdi Y, Harper L, Blanche S, Gabiano C, de José Gomez I, Notheis G, Gibb DM, Giaquinto C and Faye A for the PENTA 7 committees

Published in: 14th Conference on Retroviruses and Opportunistic Infections, 25th-28th February 2007, Los Angeles. Poster 722 Abstract R -151 

3TC+ABC maintains virological superiority over ZDV+3TC and ZDV+ABC beyond 5 years in children: the PENTA 5 trial

2007

Authors: Gibb DM, Green H, Saidi Y, et al; on behalf of PENTA 5.

Published in: AIDS.2007;21(8):947-955

Objective To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.

Design PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).

A comparison of the association of current CD4 cell count with the short-term risk of AIDS and death in HIV-infected children and adults.

2007

Authors: Dunn D, Woodburn P, Duong T, Phillips A, Gibb DM and Porter K on behalf of HPPMCS and CASCADE.

Published in: 14th Conference on Retroviruses and Opportunistic Infections, 25th-28th February 2007, Los Angeles. Poster 700

Pharmacokinetic and virological evaluations after stopping NNRTIs in children: a substudy of the PENTA 11 (TICCH) trial

2006

Authors:  Lallemant M, Burger D, Lyall H, Buck L, Compagnucci A, Ramos Amador J.T, Mellado Pena M, Fregonese F, Campbell S, Rampon O, Castelli-Gattinara G, Cressey, Khoo S, Tréluyer J.-M, Green H, Saidi Y, Nadal D, Giaquinto C, Gibb D.M on behalf of the PENTA 11 study group.

Published in: XVI International AIDS Conference, Toronto, 13-18 August 2006. Poster MOPE0206

Considerations in the design of randomized controlled trials evaluating the optimal time to initiate antiretroviral therapy in previously untreated HIV-1 infected patients.

2006

Authors: Babiker AG and Gibb DM.

Published in: Current Opinion in HIV and AIDS 2006; 1(6):488-494

Predictive value of absolute CD4 cell count for disease progression in untreated HIV-1-infected children

2006

Authors: HIV Paediatric Prognostic Markers Collaborative Study.

Published in: AIDS 2006; 20:1289-1294

Adherence and acceptability of once daily lamivudine and abacavir in HIV-1 infected children

2006

Authors: LeProvost M, Green H, Flynn J, et al; on behalf of the PENTA 13 study group.

Published in: Pediatr Infect Dis J. 2006;25(6):533-7

Background Data on adherence to and acceptability of once daily lamivudine and abacavir are few.

Methods Twenty-four U.K. human immunodeficiency virus type-1 infected children 2-13 years of age participated in the Pediatric European Network for the Treatment of AIDS (PENTA) 13 single arm,

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

2006

Authors: Aboulker J-P, Babiker A, Bacheler L, et al. On behalf of the PENTA 8 study group

Published in: Antivir Ther. 2006;11(7):857-867

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 >

Withdrawal of Pneumocystis jirovecii prophylaxis in HIV-infected children under highly active antiretroviral therapy.

2005

Authors: Urschel S, Ramos J, Mellado M, Giaquinto C, Verweel G, Schuster T, Niehues T, Belohradsky B, Wintergerst U; the European PCP-withdrawal Study Group.

Published in: AIDS. 2005 Dec 2;19(18):2103-2108.

A randomised trial of resistance testing versus no resistance testing in children with virological failure: the PERA (PENTA 8) trial

2005

Authors: Giaquinto C, Green H, De Rossi A, et al. On behalf of the PENTA 8 study group.

Published in: 3rd IAS Conference on HIV Pathogenesis and Treatment, 24-27 July 2005, Rio de Janerio. Oral and poster presentation WeOa0106

Abstract The development of resistance to antiretroviral drugs is considered to be an important cause of treatment failure in HIV infection.

Adherence and acceptability of once daily lamivudine and abacavir in HIV-1 infected children

2005

Authors: LeProvost M, Green H, Flynn J, et al: on behalf of the PENTA 13 study group.

Published in: 3rd IAS Conference on HIV Pathogenesis and Treatment, 24-27 July 2005, Rio de Janerio. Poster MoPe9.2C03

Lower scores of Nelfinavir metabolite M8 were associated with virological failure vertically infected children in the PENTA 7study.

2005

Authors: Compagnucci A, Saïdi Y, Gibb DM, Rampon O, Ramos Amador JT, Feiterna Sperling C, Reliquet V, Giaquinto C, Navarro ML, Girard S, Harper L, Burger D, Treluyer JM, Aboulker JP, Jacqz-Aigrain E and Faye A on behalf of the PENTA 7 Study group.

Published in: 3rd IAS Conference on HIV Pathogenesis and Treatment, 24-27 July 2005, Rio de Janerio. Abstract MoPe9.2C15

Use of total lymphocyte count for informing when to start antiretroviral therapy in HIV-infected children: a meta-analysis of longitudinal data.

2005

Authors: HIV Paediatric Prognostic Markers Collaborative Study Group.

Published in: Lancet 2005; 366: 1868-74 .

Pharmacokinetics of once versus twice daily lamivudine and abacavir. Simplification of combination treatment in HIV-1 infected children (Penta 13)

2005

Authors: Bergshoeff A, Burger D, Verweij C, et al; on behalf of the PENTA 13 study group

Published in: Antivir Ther. 2005; 10:239-246

Background There are few data on plasma and intracellular pharmacokinetics (PK) of once-daily (q24h) nucleoside analogues in HIV-infected children.

Methods Children aged 2-13 years receiving combination treatment containing lamivudine (3TC) (4 mg/kg) and/or abacavir (ABC) (8 mg/kg) twice daily (q12h) were included in this single-arm,

Relationship between changes in thymic emigrants and cell-associated HIV-1 DNA in HIV-1 infected children initiating antiretroviral therapy

2005

Authors: De Rossi A, Walker AS, De Forni D, Klein N, Dibb DM. Paediatric European Network for Treatment of AIDS (PENTA)

Published in: Antivir Ther. 2005;10(1):63-71

Objectives and Methods To investigate the relationship between cell-associated HIV-1 dynamics and recent thymic T-cell emigrants, HIV-1 DNA and T-cell receptor rearrangement excision circles (TREC, a marker of recent thymic emigrants) were measured in peripheral blood mononuclear cells in 181 samples from 33 HIV-1-infected children followed for 96 weeks after antiretroviral therapy(ART) initiation.

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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