A recent, scheduled interim data and safety review of a clinical study comparing anti-HIV treatment regimens based on either nevirapine (NVP) or ritonavir-boosted lopinavir (LPV/r) has found LPV/r to be more effective than NVP in HIV-infected children who received a single dose of NVP at birth.
The International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT) is supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the NICHD. At the time of the interim review, this Phase II clinical trial, known as P1060, had enrolled 286 children ages 6 to 35 months at nine sites in six countries: India, Malawi, South Africa, Uganda, Zambia and Zimbabwe.
As a result of the review, the study team has stopped enrolling children who received single-dose NVP at birth. In addition, the team has advised the parents and guardians of children who received single-dose NVP at birth and have been taking the NVP-based treatment regimen as part of the study to consult with their providers about the best regimen for their children. The team will continue to follow these children as planned.
Meanwhile, the study will continue to compare the effectiveness of NVP-based treatment regimens versus LPV/r-based regimens in HIV-infected children who did not receive single-dose NVP at birth.
For complete details on the finding, please visit Bulletin: Lopinavir Proves Superior to Nevirapine in HIV-Infected Infants Who Received Single-Dose Nevirapine at Birth.
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