Status:
COMPLETED
Treatment Options for Protease Inhibitor-exposed Children
Lead Sponsor:
Columbia University
Collaborating Sponsors:
University of Witwatersrand, South Africa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV/AIDS
HIV Infections
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
The investigators hypothesize that switching to a regimen based on efavirenz will be as effective and safe as remaining on a regimen based on Lopinavir/ritonavir for HIV-infected children. The invest...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- HIV-infected child 3 to 5 years of age at time of screening for this trial if enrolled from outside or any age if enrolled from control arm of Neverest II.
- Reliable history or documented exposure to NVP used as part of PMTCT
- Initiated antiretroviral therapy with LPV/r at age less than 36 months
- Receiving LPV/r-based ART for at least 12 months
- At least one viral load measurement less than 50 copies/ml conducted as part of screening for the study
- ALT measurement grade I or less (DAIDS Toxicity Tables 2004) (Appendix A). These may be repeated until ALTs normalize if necessary.
- Exclusion criteria:
- Prior treatment with any NNRTI drug as part of a therapeutic regimen
- Substitution of other NRTI drugs (instead of 3TC and D4T which are the standard first line regimen) will be allowed.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01146873
Start Date
July 1 2010
End Date
December 1 2014
Last Update
March 13 2017
Active Locations (1)
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1
Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng, South Africa