NCT01196195 - KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18) | Biotech Hunter

Enrollment

173

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

July 31, 2012

Study Completion Date

August 31, 2013

Conditions

Antiretroviral Therapy in HIV-1 Infected Children

Interventions

DRUG

Kaletra dosed once daily

Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = once daily.

DRUG

kaletra dosed twice daily

Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = twice daily.

Trial Locations (17)

Program for HIV Prevention and Treatment (PHPT)/IRD 174, Changklan, Muang

Charite University Hospital Berlin, Berlin

Department of Pediatric Oncology Hematology and Immunology KA02, Düsseldorf

J W Goethe University, Frankfurt

Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital, Munich

Our Lady's Children's Hospital, Dublin

Emma Childrens Hospital, Amsterdam

UMC St. Radboud, Nijmegen

HIV-NAT Thai Red Cross AIDS Research Centre, Bangkok

Birmingham Heartlands Hospital, Birmingham

University Hospital Bristol, Bristol

Evelina Children's Hospital, London

Great Ormond Street Hospital, London

King's College Hospital, London

St. Mary's Hospital, London

Nottingham City Hospital Campus, Nottingham

John Radcliffe Hospital, Oxford