Status:
COMPLETED
A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
4+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 in...
Detailed Description
Because of previous exposure to nevirapine or other non-nucleoside reverse transcriptase inhibitors (NNRTIs), either by direct treatment or through their mothers in pregnancy, infants must often recei...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01172535
Start Date
November 1 2010
End Date
December 1 2013
Last Update
November 5 2021
Active Locations (19)
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1
University of California, UC San Diego CRS
La Jolla, California, United States, 92093-0672
2
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80045
3
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, United States, 02118
4
SOM Federal University Minas Gerais Brazil NICHD CRS
Belo Horizonte, Minas Gerais, Brazil, 30130-100