Publications

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.

Three year outcomes in children treated with HAART before 3 months of age in the PENTA 7 trial.

2004

Authors: Compagnucci A, Saïdi Y, Harper L, Navarro ML, Girard S, Walker AS, Debré M, Gibb DM, Rampon O, Lachassine E, Schmitz T, Giaquinto C, Aboulker JP, Fay

Published in: XV International AIDS Conference, 11-16 July 2004, Bangkok. Abstract B11956.

Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome

2004

Authors: Aboulker JP, Babiker A, Chaix ML, et al; Paediatric European Network for Treatment of AIDS.

Published in: AIDS. 2004.23;18(2):237-45

Objective To assess the feasibility and impact of highly active antiretroviral therapy (HAART) started in vertically HIV-1-infected infants less than 3 months of age.
Methods Adverse events, plasma HIV-1 RNA,

PENTA guidelines for the use of antiretroviral therapy 2004

2004

Authors: Sharland M, Blanche S, Castelli G, Ramos J, Gibb DM for the PENTA Steering Committee.

Published in: HIV Med 2004; 5, (Suppl. 2), 61-86

72-week follow-up of HAART started in infants aged less than 3 months: CD4, viral load and drug resistance outcomes in the PENTA 7 study

2004

Authors: Writing Committee (alphabetical): Aboulker J-P, Babiker A, Chaix ML, Compagnucci A, Darbyshire JH, Debré M, Faye A, Giaquinto C, Gibb DM, Harper L, Saidi Y, Walker AS

Published in: AIDS 2004;18 (2):237-245

Objective To assess the feasibility and impact of highly active antiretroviral therapy (HAART) started in vertically HIV-1-infected infants less than 3 months of age.

Maintaining the nelfinavir trough concentration above 0.8 mg/L improves virologic response in HIV-1-infected children

2004

Authors: Burger DM, Bergshoeff A, de Groot R, et al; on behalf of the PENTA 5 study group.

Published in: J Paediatr 2004;145(3):403-405

Abstract Differences in virologic response were compared in 32 HIV-infected children with a nelfinavir trough concentration either below (n=7) or above (n=25) 0.8 mg/L. Virologic response at week 48 was observed in 29% of children with subtherapeutic nelfinavir troughs versus 80% in children with therapeutic nelfinavir troughs (P=.02)

Effect of concurrent zidovudine use on the resistance pathway selected by abacavir-containing regimens

2004

Authors: Lanier ER, Givens N, Stone C, et al.

Published in: HIV Med. 2004;5(6):394-399

Objectives Abacavir (ABC) selects for four mutations (K65R, L74V, Y115F and M184V) in HIV‐1 reverse transcriptase (RT), both in vitro and during monotherapy in vivo. The aim of this analysis was to compare the selection of these and other nucleoside reverse transcriptase inhibitor (NRTI)‐associated mutations by ABC‐containing therapies in the presence and absence of concurrent lamivudine (3TC) and/or zidovudine (ZDV) and to assess the effect of these mutations on phenotypic susceptibility to the NRTIs.

Pharmacokinetics (PK) of once daily versus twice daily Lamivudine and Abacavir in HIV-1 infected children: PENTA 13

2004

Authors: Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, LeProvost M, Walker AS, Novelli V, Lyall H, Gibb DM.

Published in: 11th Conference of Retroviruses and Opportunistic Infections, San Francisco, 8-11 February 2004. Poster 934.

Impact of NFV and its active metabolite M8 trough levels on virologic response from primary HIV-1 vertically infected children treated with d4T, ddI and NFV in the PENTA 7 study.

2003

Authors: Compagnucci A, Saidi Y, Faye A, et al.

Published in: 2nd IAS Conference on HIV Pathogenesis and Treatment, 13-16 July Paris. Poster 1095

Short-term risk of disease progression in HIV-1 infected children receiving no antiretroviral therapy or zidovudine monotherapy: estimates according to CD4 percent, viral load, and age.

2003

Authors: HIV Paediatric Prognostic Markers Collaborative Study Group.

Published in: Lancet 2003; 362:1605-11.

Pharmacokinetics of Nelfinavir and its Active Metabolite, hydroxy-tert-butylamide, in Infants Perinatally Infected with HIV-1.

2003

Authors: Litalien C, Faye A, Compagnucci A, Giaquinto C, Harper L, Gibb DM, Jacqz-Aigrain E for PENTA.

Published in: Pediatr Inf Dis J 2003; 22(1):48-55

Background In children younger than 2 years of age vertically infected with HIV-1, the recommended pediatric dosing regimen for nelfinavir (20 to 30 mg/kg three times a day) provides insufficient drug exposure.

Three year follow-up of the PENTA 5 trial

2003

Authors: Gibb DM, Giaquinto C, Walker AS, Harper L, Compagnucci A, Saidi Y, Moulinier C, Aboulker JP, Babiker AG, Debré M, Darbyshire JH on behalf of the PENTA 5 Executive Committee

Published: 10th Conference on Retroviruses and Opportunistic Infections February 10th – 14th, 2003 – Boston. Poster G1-12

Relationship between Cell-Associated HIV-1 DNA and Thymic Output in HIV-1 infected Children Initiating Antiretroviral Therapy in the PENTA 5 Trial

2003

Authors: De Rossi A, Walker AS, De Forni D, Gibb DM on behalf of PENTA.

Published in: 10th Conference on Retroviruses and Opportunistic Infections February 10th – 14th, 2003 – Boston. Poster P-17

Adherence to Prescribed Antiretroviral Therapy in Human Immunodeficiency Virus-Infected Children in the PENTA 5 Trial

2003

Author: Gibb DM, Goodall RL, Giacomet V, McGee L, Compagnucci A, Lyall H. Paediatric European Network for Treatment of AIDS Steering Committee.

Published in: Pediatr Infect Dis J. 2003;22(1):56-62

Background Most studies of adherence to highly active antiretroviral therapy in children have been retrospective or cross-sectional. Factors relating to the caregiver, the child and the medication are all considered to be important for good adherence.

Zidovudine (ZDV) appears to prevent selection of K65R and L74V, mutations normally selected by Abacavir (ABC) mono- or combination therapies not containing ZDV

2002

Authors: Ait-Khaled M, Lanier R, Richards N, Stone C, Griffin P, Gibb DM, Walker AS, Craig C, Loeliger E, Tisdale M

Published in: 2002 International Meeting of the Institute of Human Virology, September 9th-13th, 2002, Baltimore

Adherence to HAART in children: results from a questionnaire study of children in PENTA 5 trial

2002

Authors: Giacomet V, Gibb DM, Goodall R, McGee L, Walker AS, Giaquinto C.

Published in: XIV World AIDS Conference, 7th-12th July 2002, Barcelona, Spain. Poster TuPpB2050

96 week follow-up of the PENTA 5 trial; comparing ZDV+3TC, ZDV+ABC and 3TC+ABC with or without NFV in ART naive children

2002

Authors: Gibb DM, Walker AS, Giaquinto C, Harper L, Compagnucci A, Saidi Y, Aboulker JP, Babiker A, Debré M, Darbyshire JH on behalf of the PENTA 5 Steering Committee.

Published in: XIV World AIDS Conference, July 7th-12th 2002, Barcelona, Spain- Poster TuPpB2051

PENTA guidelines for the use of antiretroviral therapy in paediatric HIV infection.

2002

Authors: Sharland M, Castelli Gattinara G, Tomas Ramos J, Blanche S, Gibb DM for the PENTA Steering Committee.

Published in: HIV Med 2002; 3:215-226

Biphasic decay of cell-associated HIV-1 DNA in HIV-1 infected children on antiretroviral therapy

2002

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

Published in: AIDS. 2002;16(14):1961-1963

Impact of HIV-1 subtypes on virologic response and emergence of drug resistance

2002

Authors: Pillay D, Walker AS, Gibb DM, De Rossi A, Kaye S, Ait-Khaled M, Muñoz-Fernandez M, Babiker A. for the PENTA Steering Committee.

Published in: J Infect Dis 2002; 186: 617-25

Abstract The association between virologic response and human immunodeficiency virus type 1 (HIV-1) subtype was investigated in 113 HIV-1-infected children randomly assigned to receive zidovudine plus lamivudine,

Evolution of antiretroviral phenotypic and genotypic drug resistance in antiretroviral naïve HIV-1 infected children treated with abacavir/lamivudine, zidovudine/lamivudine or abacavir/zidovudine, with or without nelfinavir (the PENTA 5 trial)

2002

Authors: Gibb DM, Walker AS, Kaye S, et al.

Published in: Antivir Ther. 2002;7(4):293-303

Purpose and Methods To describe the evolution of resistance to zidovudine (ZDV), lamivudine (3TC), abacavir (ABC) and nelfinavir (NFV), 113 previously untreated children in the PENTA 5 trial had resistance assayed at baseline, rebound and/or 24, 48, 72 weeks (VIRCO: phenotyping and genotyping with ‘Virtual Phenotype’

Increased thymic output after initiation of antiretroviral therapy in human immunodeficiency virus type 1-infected children in the Paediatric European Network for Treatment of AIDS (PENTA) 5 Trial

2002

Authors: De Rossi A, Walker AS, Klein N, De Forni D, King D, Gibb DM.

Published in: J Infect Dis 2002; 186:312-20

Abstract To investigate the thymic contribution to immune reconstitution during antiretroviral therapy (ART), T cell receptor gene rearrangement excision circles (TRECs) were measured in peripheral blood mononuclear cells (PBMC) and CD4 cells from 33 human immunodeficiencyvirus (HIV) type 1-infected children monitored for 96 weeks after ART initiation.

Comparison of dual nucleoside-analogue reverse-transcriptase inhibitor regimens with and without nelfinavir in children with HIV-1 who have not previously been treated: the PENTA 5 randomised trial

2002

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

Published in: Lancet.2002;359(9308):733-740

Introduction Treatment options for children with HIV-1 are limited. We aimed to compare activity and safety of three dual-nucleoside analogue reverse-transcriptase inhibitor (NRTI) regimens with or without a protease inhibitor in previously untreated children with HIV-1.

Methods In our multicentre trial,

Difficulties in achieving suppression of viral replication in vertically HIV-1 infected infants early treated with d4T+ddI+NFV : The PENTA 7 Study.

2002

Authors: Compagnucci A, Saidi Y, Chaix ML, et al.

Published in: 9th Conference on Retroviruses and Opportunistic Infections February 24-28, 2002 – Seattle. Poster 809 – W.

TREC Response to Antiretroviral Therapy in HIV-infected Children in the PENTA 5 Trial

2002

Authors: De Rossi A, Klein N, Walker AS, De Forni D, Babiker A, King D, Gibb DM for the PENTA Group.

Published in: 9th Conference on Retroviruses and Opportunistic Infections, February 24th-28th , 2002 – Seattle. Poster 807-W.

The Impact of HIV-1 Subtypes on Virological Response and Emergence of Resistance in the PENTA 5 Trial

2002

Authors: Pillay D, Gibb DM, Walker AS, De Rossi A, Kaye S, Ait-Khaled M, Muñoz-Fernandez M, Babiker A for the PENTA Group.

Published in: 9th Conference on Retroviruses and Opportunistic Infections, February 24th-28th, 2002 – Seattle. Poster 813-W

Pharmacokinetics (PK) of Nelfinavir (NFV) and its Active Metabolite (M8) in Very Young Infants Infected with Human Immunodeficiency Virus (HIV)

2001

Authors: Litalien C, Faye A, Compagnucci A, Jacqz-Aigrain E.

Published in: Pediatric Academic Societies 2001 Annual Meeting, April 28th – May 1st 2001, Baltimore MD. Abstract 2609.

Evolution of drug resistance in antiretroviral therapy-naïve children in PENTA 5

2001

Authors: Loveday. C., Walker. A.S., Gibb. D.M., on behalf of the PENTA virology Group

Published in:  Fifth International Workshop on HIV Drug Resistance and Treatment Strategies, 2001, Scottsdale, USA. Abstract  109

T cell repopulation in HIV infected children on highly active anti-retroviral therapy (HAART)

2001

Authors: King D J.S., Gotch F M., Larsson-Sciard E.

Published in: Clin Exp Immunol.2001;125(3):447-454

Abstract In this pilot study, we address the nature of the re-population of the T-cell compartment in HIV-1+ (Human Immunodeficiency Virus 1), vertically infected children placed on successful regimens of HAART (highly active anti-retroviral therapy) incorporating 2 NRTI and a protease inhibitor.

Evaluation of Toxicity, Tolerability and Antiviral Activity of Early d4T+ddI+Nelfinavir (NFV) Therapy in HIV-1 Vertically Infected Infants : 24 Week Preliminary Results from the PENTA 7 Study

2001

Authors: Faye A , Compagnucci A., Saidi Y; for the PENTA 7 Executive Committee

Published in: 8th Conference on Retroviruses and Opportunistic Infections, February 4th-8th, 2001, Chicago. Poster 678

Nelfinavir doses should be increased in infants less than 3 months

2000

Authors: Litalien C. Giaquinto C. Faye A. Mechinaud F. Grosch I. Compagnucci A. Jacqz-Aigrain E.

Published in: XIII International AIDS Conference July 9th-14th 2000, Durban, South Africa. Abstract Mo PEB 2213

PENTA 7 is a phase I/II multi-centre trial to evaluate the efficacy, safety and pharmacokinetics of nelfinavir, used in combination with didanosine and stavudine in HIV-infected infants of less than three months of age.

Current evidence for the use of pediatric antiretroviral therapy – a PENTA analysis

2000

Authors: Sharland M, Gibb DM, Giaquinto C.

Published in: European Journal of Pediatrics 2000; 159:649-656.

Variable use of therpaeutic interventions for children with human immunodeficiency virus type 1 infection in Europe.

2000

Authors: Bernardi S, Thorne C, Newell ML, Giaquinto C,Tovo PA, Rossi P.

Published in: European Journal of Pediatrics 2000; 159(3):170-5

Reconstitution of the T-cell Pool in Treated, HIV-infected Children

2000

Authors: King D, Gibb DM, Gotch F, Larsson-Sciard E.

Published in: 7th Conference on Retroviruses and Opportunistic Infections, January 30th- February 2nd, 2000, Abstract 322., San Francisco. Abstract 322

Immune repopulation after HAART in previously untreated HIV-1 infected children

2000

Authors: Gibb DM, Newberry A, Klein N, de Rossi A, Grosch-Wörner I, Babiker A

Published in: Lancet.2000; 355: 1331-2

Abstract In 25 vertically HIV-infected children receiving highly-active antiretroviral therapy, a 3-log10 reduction in plasma HIV RNA load was maintained for 1 year and was associated with a doubling of the CD4-cell percentage. Most (75%) new CD4 cells carried the CD45RA marker of naive cells and there was only a small rise in memory cells (CD45RO).

A randomised trial evaluating three NRTI regimens with and without Nelfinavir in HIV-infected children: 48 week follow-up from the PENTA 5 trial

2000

Authors: Gibb. D. M. for the PENTA 5 Executive and the PENTA Steering Committee.

Published in: Oral presentation at 5th International Congress on Drug Therapy in HIV Infection, Glasgow 22-26 October 2000 also published in AIDS 2000, Vol 14, supp4 p.58 (abstractPL6.8)

Drug resistance in a trial of nucleoside analogue and protease inhibitor therapy in children (PENTA 5)

2000

Authors: Kaye S. on behalf of the PENTA Virology Committee.

Published in: 5th International Congress on Drug Therapy in HIV Infection, October 22nd-26th 2000, Glasgow. P_308.

Parents’ attitudes to their HIV-infected children being enrolled into a placebo-controlled trial: the PENTA 1 trial. Paediatric European Network for Treatment of AIDS

1999

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

Published in: HIV Med. 1999;1(1):25-31

Objective The study aimed to explore the experience of parents/care-givers to their child’s participation in a European randomized trial of immediate (zidovudine) with deferred (placebo) antiretroviral treatment in asymptomatic children with vertically acquired HIV infection (PENTA 1 trial).

Design One hundred and thirty-three questionnaires were distributed to parents/care-givers (68% of children in the trial) through their paediatrician prior to unblinding the individual child’s therapy (zidovudine/placebo) and 84 (63% response rate) were returned.

Plasma viral load and genotypic resistance patterns in children adding lamivudine to current reverse transcriptase inhibitor therapy (PENTA 4 Trial)

1998

Authors:  Kaye S, Loveday C, Gibb DM., Newberry A.

Published in: 4th International Congress, November 8ht-12th 1998, Glasgow.  P_305

A randomized double-blind trial of the addition of lamivudine or matching placebo to current nucleoside analogue reverse transcriptase inhibitor therapy in HIV-infected children: the PENTA-4 trial

1998

Authors: Aboulker JP, Babiker A, Carrière I, et al.

Published in: AIDS.1998;12(14):F151-F160

Objective To evaluate the toxicity, tolerability and effect on laboratory markers of adding lamivudine (3TC) to nucleoside analogue reverse transcriptase inhibitors (NRTI) in children with HIV-1 infection.

Methods HIV-1-infected children on stable NRTI therapy were randomized to receive 3TC syrup or tablets (4 mg/kg twice daily) or matching placebo in addition to existing therapy.

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