A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines

Completed · Phase 2/Phase 3

Conditions studied: HIV

In brief

Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to infant drug resistance, this dosing is often complicated and impractical in busy clinical settings. To address this, the World Health Organization (WHO) has released a simplified dosing table based on infant weight bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants when dosed according to the new WHO guidelines.

Key facts

Study ID

NCT01172535

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

97

Starts

2010-11-01

Expected to finish

2013-12-01

Last updated by the study team

2021-11-05

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weight equal to or greater than 3 kg, but less than 25 kg, at the time of enrollment
• Confirmed diagnosis of HIV-1 infection
• Lopinavir/ritonavir (LPV/r)-treatment naïve and LPV/r-treatment eligible as defined by country-specific guidelines or the WHO pediatric treatment guidelines and confirmed by investigator
• Willingness to take two nucleoside reverse transcriptase inhibitos (NRTIs), in accordance with appropriate national or international treatment guidelines
• Demonstrated ability and willingness to swallow tablets for children larger than 10 kg. This can be assessed before inclusion (for example, a test trial with similar size solid tablet such as tic-tac).
• Participants in the weight band between 10 and 16.9 kg that are unable to swallow tablets will receive liquid formulation
• Parent or legal guardian able and willing to provide written informed consent

You may not qualify if…

• Planned concurrent use of non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors, or an entry inhibitor
• Planned concurrent protease inhibitor (PI) use, other than LPV/r
• Prior treatment with LPV/r. Prior treatment with other PIs is allowed.
• Results of certain laboratory tests indicating adverse events of Grade 3 or greater
• Results of a lipase test indicating adverse event of Grade 2 or greater or clinical evidence of pancreatitis within 30 days prior to study entry
• Tuberculosis co-treatment with rifampicin-containing regimen
• Treatment with any enzyme-inducing antiepileptic drugs, such as henobarbital, phenytoin or carbamazepine
• Clinical condition requiring the use of a prohibited medication (see protocol for more details)
• Clinically unstable child requiring acute treatment for a serious opportunistic infection
• Chemotherapy for active malignancy
• Any clinically significant diseases (other than HIV-1 infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise participation in this study
• Treatment with experimental drugs for any indication within 30 days prior to study entry
• Known history of cardiac conduction abnormality and/or underlying structural heart disease, including congenital long QT

Where it is running

• University of California, UC San Diego CRS — La Jolla, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Boston Medical Center Ped. HIV Program NICHD CRS — Boston, Massachusetts, United States
• SOM Federal University Minas Gerais Brazil NICHD CRS — Belo Horizonte, Minas Gerais, Brazil
• Hosp. Santa Casa Porto Alegre Brazil NICHD CRS — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Federal dos Servidores do Estado NICHD CRS — Rio de Janeiro, Brazil
• Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS — Rio de Janeiro, Brazil
• Hosp. Geral De Nova Igaucu Brazil NICHD CRS — Rio de Janeiro, Brazil
• Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS — São Paulo, Brazil
• Univ. of Sao Paulo Brazil NICHD CRS — São Paulo, Brazil
• Shandukani CRS — Johannesburg, Gauteng, South Africa
• Family Clinical Research Unit (FAM-CRU) CRS — Tygerberg, Western Cape, South Africa
• Bhumibol Adulyadej Hosp. CRS — Saimai, Bangkok, Thailand
• Siriraj Hospital Mahidol University CRS — Bangkok, Bangkoknoi, Thailand
• Prapokklao Hosp. CRS — Chanthaburi, Thailand
• Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS — Chiang Mai, Thailand
• Chiangrai Prachanukroh Hospital CRS — Chiangrai, Thailand
• Chonburi Hosp. CRS — Chon Buri, Thailand
• Phayao Provincial Hosp. CRS — Phayao, Thailand

Full record on ClinicalTrials.gov

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