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.
Please direct media inquiries for NIAID to Laura Sivitz at (301) 402-1663, sivitzl@niaid.nih.gov.
Please direct media inquiries for NICHD to Robert Bock at (301) 496-5133, bockr@mail.nih.gov.
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NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
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