We conducted a randomized, open-label, non-inferiority trial between June 2010 and December 2013 at Rahima Moosa Mother and Child Hospital in Johannesburg, South Africa. Children were randomized to switch to efavirenz-based therapy or to continue on ritonavir-boosted lopinavir-based therapy and were followed for 48 weeks after randomization. The non-inferiority design was chosen as efavirenz was not expected to have better virologic outcomes than the standard regimen. The study was approved by the Institutional Review Boards of Columbia University and the University of the Witwatersrand. The child’s mother or legal guardian provided signed informed consent.
Children were eligible for enrollment if they had nevirapine exposure as part of PMTCT, were currently receiving ritonavir-boosted lopinavir-based therapy started <36 months of age provided for at least one year, and had an HIV RNA test <50 copies/ml. All children in the control arm of our prior trial10 (link),11 (link) still in follow-up were screened for eligibility. In addition, clinicians responsible for the care of HIV-infected children at other clinics in the area were approached about referring children meeting our eligibility criteria. Random assignments were generated by the study statistician using a permuted block design with block sizes between 8 and 12 and were concealed in opaque envelopes opened on-site at the time of randomization. Children were followed at 4, 8, 16, 24, 32, 40, and 48 weeks after randomization.
Children were eligible for enrollment if they had nevirapine exposure as part of PMTCT, were currently receiving ritonavir-boosted lopinavir-based therapy started <36 months of age provided for at least one year, and had an HIV RNA test <50 copies/ml. All children in the control arm of our prior trial10 (link),11 (link) still in follow-up were screened for eligibility. In addition, clinicians responsible for the care of HIV-infected children at other clinics in the area were approached about referring children meeting our eligibility criteria. Random assignments were generated by the study statistician using a permuted block design with block sizes between 8 and 12 and were concealed in opaque envelopes opened on-site at the time of randomization. Children were followed at 4, 8, 16, 24, 32, 40, and 48 weeks after randomization.
