Last updated on December 2012

A Trial of Lopinavir/Ritonavir Dosed According to the Who Pediatric Weight Band Dosing Guidelines

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV Infection
  • Age: - 100 Years
  • Gender: Male or Female
  • Other:
    Weight greater than or equal to 3kg and less than or equal to 25 kg at the time of
    Past or current documentation of a confirmed diagnosis of HIV-1 infection defined as two
    positive assays from two different samples. At least one of the specified assays must be
    performed in an AIDS Clinical Trials Group (ACTG)/ International Maternal Pediatric
    Adolescent AIDS Clinical Trials Group (IMPAACT) certified laboratory. The two results may
    be in any combination of the following:
    LPV/r-treatment naïve and LPV/r-treatment eligible as defined by country-specific
    guidelines or the WHO pediatric treatment guidelines confirmed by investigator.
    Willingness to take two NRTIs, in accordance with appropriate national or international
    treatment guidelines.
    Demonstrated ability and willingness to swallow tablets for children greater than 10 kg.
    Note # 1: This can be assessed before inclusion (for example, a test trial with similar
    ize solid tablet such as tic-tac).
    Note # 2: Subjects on the weight band 10-16.9 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 be eligible for this study if the following are true:

  • Planned concurrent use of nonnucleoside reverse transcriptase inhibitor (NNRTI), integrase
    inhibitors, or entry inhibitor.
    Planned concurrent PI use, other than LPV/r.
    Prior treatment with LPV/r (prior treatment with other PIs is allowed).
    Any of the following laboratory tests within 30 days prior to study entry classified as
    greater than or equal to Grade 3 (see Division of AIDS [DAIDS] Table for Grading the
    Severity of Adult and Pediatric Adverse Events, Version 1.0 [December 2004], Clarification
    August, 2009, neutrophil count, hemoglobin, platelets, AST,
    ALT, or serum creatinine.
    A greater than or equal to Grade 2 lipase 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 phenobarbital, phenytoin
    or carbamazepine).
    Clinical condition requiring the use of a prohibited medication
    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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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