Publications

Ritonavir pharmacokinetics in pregnancy

2015

Authors: Colbers A, Clotet V, Burger D.

Published: 16th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, May 26th – 28th 2015, Westin Alexandria

 

Etravirine pharmacokinetics during pregnancy and postpartum

2015

Authors: Best B, Colbers A, Wang J, Taylor G, Stek A, van Kasteren M, Mirochnick M, Burger D.

Published: 24th Conference on Retroviruses and Opportunistic Infections, March 23rd-26th 2015, Seattle. P_892

 

Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

2015

Authors: Colbers A, Best B, Schalkwijk S, et al. PANNA Network and the IMPAACT 1026 Study Team.

Published in: Clin Infect Dis. 2015; 61(10):1582-1589.

Objective To describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)–infected women during pregnancy and post partum.

Methods HIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery.

I am scared of getting caught up in my lie’: challenges to self-reported adherence for young people living with HIV

2015

Authors:  Bernays S, Seeley J, Paparini S, Rhodes T and the ARROW and BREATHER trial teams.

Published in: accepted for presentation at AIDS Impact, Amsterdam 28-31 July, 2015 (abstract 3435)

Young people, clinical trials and ‘the HIV experience’: What can similarities across time and place tell us about growing up with HIV?

2015

Authors:  Paparini S on behalf of Bernays S, Seeley S,  Rhodes T,  Namukwaya Kihika S,Kawuma-Kigawa R, Nakyambadde H, Kabajaasi O and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

“But it’s my story”: exploring the experience and effect of telling children how they have acquired HIV

2015

Authors:  Seeley J on behalf of the Bernays S, Paparini S, Namukwaya Kihika S,  Rhodes T and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

Early antiretroviral therapy in children perinatally infected with HIV: a unique opportunity to implement immunotherapeutic approaches to prolong viral remission

2015

Authors: Klein N, Palma P, Luzuriaga K, et al.

Published in: Lancet Infect Dis. 2015;15(9):1108-1114

Abstract From the use of antiretroviral therapy to prevent mother-to-child transmission to the possibility of HIV cure hinted at by the Mississippi baby experience, paediatric HIV infection has been pivotal to our understanding of HIV pathogenesis and management. Daily medication and indefinite antiretroviral therapy is recommended for children infected with HIV.

“But it’s my story”: exploring the experience and effect of telling children how they have acquired HIV

2015

Authors: Seeley J on behalf of the Bernays S, Paparini S, Namukwaya Kihika S,  Rhodes T and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

Young people, clinical trials and ‘the HIV experience’: What can similarities across time and place tell us about growing up with HIV?

2015

Author: Paparini S on behalf of Bernays S, Seeley S, Rhodes T, Namukwaya Kihika S,Kawuma-Kigawa R, Nakyambadde H, Kabajaasi O and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

‘I am scared of getting caught up in my lie’: challenges to self-reported adherence for young people living with HIV; accepted for presentation at AIDS Impact

2015

Authors: Bernays S, Seeley J, Paparini S, Rhodes T and the ARROW and BREATHER trial teams

Published in: AIDS Impact, Amsterdam 28-31 July, 2015 (abstract 3435)

The EPIICAL project: an emerging global collaboration to investigate immunotherapeutic strategies in HIV-infected children

2015

Authors: Palma P, Foster C, Rojo P, et al.

Published in: J Virus Erad. 2015;1(3):134-139.

Abstract The EPIICAL (Early-treated Perinatally HIV-infected Individuals: Improving Children’s Actual Life with Novel Immunotherapeutic Strategies) project arises from the firm belief that perinatally infected children treated with suppressive antiretroviral therapy (ART) from early infancy represent the optimal population model in which to study novel immunotherapeutic strategies aimed at achieving ART-free remission.

Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. Update Decemebr 2014

2015

Authors: Antinori A., Marcotullio S., Andreoni M., Ammassari A., d’Arminio Monforte A., Galli M., Girardi E., Mazzotta F., Mussini C., Puoti M., Lazzarin A.; Italian HIV Guidelines Working Group.

Published inNew Microbiol. 2015, 38: 299-328

Abstract: This short version complies with the intention expressed in the introduction to the full text Italian Guidelines for the use of antiretroviral drugs and the diagnostic-clinical management of people with HIV-1 infection.

Pediatric drug safety surveillance in FDA-AERS: a description of adverse events from GRIP project.

2015

Authors:  De Bie S., Ferrajolo C., Straus S.M., Verhamme K.M., Bonhoeffer J., Wong I.C., Sturkenboom M.C., GRiP network

Published in: PLoS One. 2015, 10: 0130399.

Abstract: Individual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Treating hepatitis C virus in children: time for a new paradigm

2015

Authors: Thorne C, Indolfi G, Turkova A, Giaquinto C, Nastouli E.

Published in: J Virus Erad. 2015 Jul 1;1(3):203-5.

Abstract Hepatitis C virus infection is a leading cause of liver-related morbidity and mortality. In the paediatric population, HCV infection is underdiagnosed and undertreated in the absence of robust screening policies worldwide, and a lack of tolerable,

HCV treatment in children and young adults with HIV/HCV co-infection in Europe.

2015

Authors: Turkova A, Giacomet V, Goetghebuer T, et al.

Published in: J Virus Erad. 2015;1(3):179-184

Objectives To describe use of treatment for chronic hepatitis C virus (HCV) infection in HIV/HCV co-infected children and young people living in Europe and to evaluate treatment outcomes.

Methods HCV treatment data on children and young people aged <25 years with HIV/HCV co-infection were collected in a cohort collaboration of 11 European paediatric HIV cohorts.

Once vs. twice-daily lopinavir/ritonavir in HIV-1-infected children.

2015

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

Published in: AIDS 2015. 29(18):2447-2457

Objective To evaluate whether once daily (q.d.) lopinavir/ritonavir is noninferior to twice daily (b.i.d.) dosing in children.

Design International, multicentre, phase II/III, randomized, open-label, noninferiority trial (KONCERT/PENTA18/ANRS150).

Setting Clinical centres participating in the PENTA,

Once- versus twice-daily lopinavir/ritonavir in HIV-1 infected children: a randomised controlled trial (KONCERT/PENTA18/ANRS150).

2015

Authors:

Published in: AIDS 2015, 29:2447-2457

Objective To evaluate whether once daily (q.d.) lopinavir/ritonavir is noninferior to twice daily (b.i.d.) dosing in children.

Design International, multicentre, phase II/III, randomized, open-label, noninferiority trial (KONCERT/PENTA18/ANRS150).

Setting Clinical centres participating in the PENTA, HIV-NAT and PHPT networks.

Participants Children/adolescents with HIV-1 RNA viral load less than 50 copies/ml for at least 24 weeks on lopinavir/ritonavir-containing antiretroviral therapy.

ART With Weekends Off Is Noninferior to Continuous ART in Young People on EFV+2NRTI

2015

Authors: Karina M. Butler on behalf of the BREATHER trial team

Published in: CROI 2015, Seattle, USA, Feb 23 -26 2015.

Abstract For HIV-1 infected young people (YP) facing lifelong ART, short cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity and better adherence, as well as cost savings.

Long-term consequences of planned treatment interruption in HIV-1-infected children.

2015

Authors: Freguja R, De Rossi A, Paulson H, Klein N, Del Bianco P, Compagnucci A, Saidi Y, Giaquinto C, Harper L, Gibb D, on behalf of the PENTA Steering Committee

Published in: CROI 2015, Seattle, USA, Feb 23 -26 2015. Poster presentation abstract 919

Pharmacokinetics of total and unbound darunavir in HIV-1-infected pregnant women

2015

Authors: Colbers A, Molto J, Ivanovic J, et al. PANNA Network

Published in: J Antimicrob Chemother. 2015; 70(2):534-542

Objectives To describe the pharmacokinetics of darunavir in pregnant HIV-infected women in the third trimester and post-partum.

Patients and Methods This was a non-randomized, open-label, multicentre, Phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe.

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; PENPACT-1 (PENTA 9PACTG 390) Study Team.

Published in: J Acquir Immune Defic Syndr. 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.

Atazanavir exposure is effective during pregnancy regardless of tenofovir use

2015

Authors: Colbers A, Hawkins D, HidalgoTenorio C, et al.

Published in: Antivir Ther. 2015; 20(1):57-64

Background We studied the effect of pregnancy on atazanavir pharmacokinetics in the presence and absence of tenofovir.

Methods This was a non-randomized, open-label, multicentre Phase IV study in HIV-infected pregnant women recruited from European HIV treatment centres.

Pharmacokinetics, safety and transplacental passage of rilpivirine in pregnancy: two cases

2014

Authors: Colbers A,  Gingelmaier A, van der Ende M, Rijnders, B, Burger D.

Published in: AIDS 2014;28(2): 288-290

Adherence to antiretroviral therapy in pregnancy and during the first year post-partum in HIV-positive women in Ukraine

2014

Authors: Bailey H, Townsend C, Semenenko I, Malyuta R, Cortina-Borja, Thorne C; for the Ukraine European Collaborative Study in EuroCoord

Published in: BMC Public Health. 2014; 24(14):993

Background Poor adherence to antiretroviral therapy (ART) is associated with HIV disease progression and, during

pregnancy, increased mother-to-child transmission risk. In Ukraine, access to combination ART is expanding but data

on adherence are scarce.

Effective exposure to atazanavir during pregnancy, regardless of tenofovir use

2014

Authors:  Colbers A, Hawkins D, Hidalgo-Tenorio C, van der Ende M, Kabeya K, Gingelmaier A, Weizsäcker K, Lambert J, Rockstroh J, Burger D; on behalf of the PANNA network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2014, Boston. P_892

 

A comparison of the pharmacokinetics of raltegravir during pregnancy and postpartum

2014

Authors: Blonk M, Colbers A, Hidalgo-Tenorio C, Weizsäcker K, Moltó J, Hawkins D, van der Ende M, Gingelmaier A, Taylor G, Burger D; on behalf of the PANNA network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2014, Boston. P_890

 

Low darunavir exposure during pregnancy with 800/100mg darunavir/r QD dosing

2014

Authors: Colbers A, Moltó J, Ivanovic J, Hawkins D, Sadiq T, Kabeya K,  Gingelmaier A, Weizsäcker K, Taylor G, Burger D; on behalf of the PANNA network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2014, Boston. P_887

 

Uptake and outcomes of HCV treatment in children and young adults with HIV/HCV co-infection in Europe

2014

Authors: Turkova A; for the European Paediatric HIV/HCV Co-infection Study Group in the European Pregnancy and Paediatric HIV Cohort Collaboration in EuroCoord.

Published in: 20th International AIDS Conference (AIDS 2014), July 20th-25th 2014, Melbourne, Australia.

Children living with HIV in Ukraine: response to antiretroviral therapy (ART) and duration of first-line regimens

2014

Authors: Bagkeris E, Bailey H, Malyuta R, Volokha A, Thorne C

Published in: 6th International Workshop on HIV Pediatrics, July 18th-19th  2014, Melbourne, Australia.

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.

Post-licensing safety of fosamprenavir in HIV-infected children in Europe.

2014

Authors: Judd A, Duong T, Galli L, et al; on behalf of the European Pregnancy and Paediatric HIV Cohort Collaboration study group in EuroCoord.

Published in: Pharmacoepidemiol  Drug Saf. 2014;23(3):321-5

Purpose Fosamprenavir, combined with low-dose ritonavir (FPV/r), is indicated for treatment of HIV-infected children aged ≥6 years in Europe. Our purpose was to assess the safety of licensed use of FPV/r in HIV-infected children reported to six cohorts in the European Pregnancy and Paediatric HIV Cohort Collaboration.

Pharmacokinetics of Pediatric Lopinavir/Ritonavir Tablets in Children When Administered Twice Daily According to FDA weight bands.

2014

Authors: Bastiaans DE, Forcat S, Lyall H, et al.

Published in: Pediatr Infect Dis J. 2014;33(3):301-305

Background Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval and only body surface area by the EMA.

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.

Moving on up: tracking young people with perinatal HIV as they transition to adult care in Europe

2014

Authors: Judd A, Collins J, Lodi S, Olson A, Pantazis N, Gibb DM; on behalf of the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) in EuroCoord

Published in: 18th International Workshop on HIV Observational Databases, March 27th-29th 2014, Sitges, Spain.

Double dosing of ritonavir in twice-daily darunavir-containing regimens: an example of a lack of appropriate formulations in paediatrics

2014

Authors: Judd A, Childs T, Collins J, Dodonov K, Galli L, Goetghebuer T, Konigs C, Noguera-Julian A, Rojo Conejo P, Naver L, Tookey P, Giaquinto C; on behalf of the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) in EuroCoord.

Published in: 18th International Workshop on HIV Observational Databases, March 27th-29th 2014, Sitges, Spain.

Increasing abacavir use in HIV-1-infected pregnant women in Europe: effectiveness and safety data

2014

Authors: Bailey H, Thorne C, Giaquinto C, Tookey P; for the UK and Ireland National Study of HIV in Pregnancy and Childhood and the European Collaborative Study in EuroCoord.

Published in: 18th International Workshop on HIV Observational Databases, March 27th-29th  2014, Sitges, Spain.

The Immunological and Virological Consequences of Planned Treatment Interruptions in Children with HIV Infection.

2013

Authors: Klein N, Sefe D, Mosconi I, et al; on Behalf of the Paediatric European Network for Treatment of AIDS (PENTA) 11 Trial Team

Published in: PLoS One. 2013;8(10):e76582.

Objective To evaluate the immunological and viral consequences of planned treatment interruptions (PTI) in children with HIV.

Design This was an immunological and virological sub-study of the Paediatric European Network for Treatment of AIDS (PENTA) 11 trial,

A comparison of the pharmacokinetics of maraviroc during pregnancy and postpartum

2013

Authors:  Colbers A, Brookie B, Wang J, Stek A, Hidalgo-Tenorio C, Hawkins D, Taylor G, Capparelli E, Burger D, Mirochnick M; on behalf of the PANNA network

Published: 20th Conference on Retroviruses and Opportunistic Infections, March 3rd-6th 2013, Atlanta. P_931

 

HCV treatment in children and young adults with HIV/HCV co-infection in Europe

2013

Authors: Turkova A, Thorne C, Galli L, Goetghebuer T, de Martino M, Oprea C, Ramos Amador JT, Giaquinto C; for the European Pregnancy and Paediatric HIV Cohort Collaboration in EuroCoord.

Published in: 7th International AIDS Society Conference (IAS 2013), Kuala Lumpur, 30th June – 3rd July 2013

Missed opportunities for prevention of hepatitis B infection in childbearing women with HIV in Ukraine

2013

Authors: Thorne C, Bailey H, Semenenko I, Tereschenko R, Adeyanova I, Kulakovskaya E, Ostrovskaya L, Malyuta R

Published in: 7th International AIDS Society Conference (IAS 2013), Kuala Lumpur, 30th June – 3rd July 2013

Pharmacokinetics of paediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands.

2013

Authors: D Bastiaans, S Forcat, H Lyall, T Cressey, S Chalermpantmetagul, Y Saïdi, C Koenigs,  D Nayagam, A Compagnucci, S Montero, L Harper, C Giaquinto, E Colbers, D Burger.

Published in: 31st Annual Meeting of the ESPID- May 28 – June 1, 2013, Milan: Poster discussion Abstract A-534-0018-00429. 

Vaginal delivery as an option for HIV-infected women: decreasing late preterm delivery rates in a European cohort collaboration.

2013

Authors: Aebi-Popp K, Mulcahy F, Glass T, Rudin C, Martinez de Tejada B, Bertisch B, Grawe C, Rickenbach M, Scheibner K, Hösli I and Thorne C  for the European Collaborative Study in EuroCoord and the Swiss Mother & Child HIV Cohort Study.

Published in: 5th International HIV Pediatrics Workshop, Kuala Lumpur, 28-29 June 2013.

 

Missed opportunities among HIV-positive women to control viral replication during pregnancy and to have a vaginal delivery

2013

Authors: Aebi-Popp K, Mulcahy F, Glass TR, et al.; for the European Collaborative Study in EuroCoord and the Swiss Mother & Child HIV Cohort Study.

Published in: J Acquir Immune Defic Syndr. 2013;64(1):58-65

Introduction Most national guidelines for the prevention of mother-to-child transmission of HIV in Europe updated between 2001 and 2010 recommend vaginal deliveries for women with undetectable or very low viral load (VL).

Improvements in virological control among women conceiving on cART in Western Europe

2013

Authors: Bailey H, Townsend CL, Cortina-Borja M, Thorne C; for the European Collaborative Study in EuroCoord.

Published in: AIDS 2013; 27:2312-2315

Abstract Among 396 HIV-infected women conceiving on combination antiretroviral therapy and enrolled in the European Collaborative Study in 2000–2011, the proportion with virological failure (>200 copies/ml after ≥24 weeks of treatment) declined substantially from 34% in 2000–2001 to 3% in 2010–2011.

Use of combination neonatal prophylaxis for the prevention of mother-to-child transmission of HIV infection in European high-risk infants. 

2013

Authors: Chiappini E, Galli L, Giaquinto C, et al. European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord.

Published in: AIDS 2013; 27(6): 991-1000

Objectives To evaluate use of combination neonatal prophylaxis (CNP) in infants at high risk for mother-to-child transmission(MTCT) of HIV in Europe and investigate whether CNP is more effective in preventing MTCT than single drug neonatal prophylaxis (SNP).

The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women

2013

Authors: Colbers AP, Hawkins DA, Gingelmaier A, et al.

Published in: Aids. 2013; 27(5):739-748.

Objective To describe the pharmacokinetics of tenofovir and emtricitabine in the third trimester of pregnant HIV-infected women and at postpartum.

Design A nonrandomized, open-label, multicentre phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe.

Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions in the PENTA 11 Study

2013

Authors: Bunupuradah T, Duong T, Compagnucci A, et al; on behalf of the PENTA 11 Extension Study Group

Published in: AIDS. 2013;27(4):579-89

Background Excess risks for death/opportunistic disease in adults randomized to CD4-driven planned treatment interruption (PTI) in the Strategies for Management of Antiretroviral Therapy (SMART) trial remained after antiretroviral therapy (ART) re-initiation. Risks for childrenfollowing PTI were evaluated in long-term follow-up of children in the PENTA 11 trial.

Adherence to antiretroviral therapy and acceptability of planned treatment interruptions in HIV-infected children

2013

Authors: Harrison L, Ananworanich J, Hamadache D, et al; on Behalf of the Paediatric European Network for Treatment of AIDS (PENTA) 11 Trial Team

Published in: AIDS Behav. 2013;17(1):193-202.

Abstract There have been no paediatric randomised trials describing the effect of planned treatment interruptions (PTIs) of antiretroviral therapy (ART) on adherence, or evaluating acceptability of such a strategy.

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

2012

Authors: Colbers A, Taylor G, Moltó J, Ivanovic J, Wyen C, Schwarze-Zander C, Weizsäcker K, Gingelmaier A, Hawkins D, Sadiq T, Kabamba K, Burger D; on behalf of the PANNA network

Published: 13th International Workshop on Clinical Pharmacology of HIV Therapy, 2012 April 16th-18th, Barcelona

 

A comparison of the pharmacokinetics of darunavir, atazanavir and ritonavir during pregnancy and post-partum

2012

Authors: Colbers A, Moltó J, Ivanovic J, Hidalgo-Tenori C, Weizsäcker K, van der Ende I, Hawkins D, Taylor G, Sadiq T,  Burger D; on behalf of the PANNA network

Published: 19th Conference on Retroviruses and Opportunistic Infections, March 5th-8th 2012, Seattle. P_103

 

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