Review of the HIVNET 012 Perinatal HIV Prevention Study (2005) / Chapter Skim
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Appendix B: Comparisons to Other Perinatal HIV Prevention Studies Using NVP and AZT
Appendix B: Comparisons to Other Perinatal HIV Prevention Studies Using NVP and AZT
Pages 113-129
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From page 113... ...
Appendix B Comparisons to Other Perinatal HIV Prevention Studies Using NVP and ZDV INTRODUCTION This review compares primary and secondary outcomes from the HIVNET 012 trial with results from similar study arms in other trials. Specifically this review describes the range and weighted mean average of the effects of the simplified maternal-infant nevirapine (NVP)
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114 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY Types of Interventions Nevirapine or zidovudine administered both in the intrapartum period, i.e., labor, to HIV-infected mothers and/or in the immediate postpartum period to exposed infants. In HIVNET 012 the NVP regimen was 200 milligrams (mg)
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APPENDIX B 115 mother-to-child transmission. Searched databases included MEDLINE, AIDSLINE, the Cochrane Controlled Trials Register and EMBASE.
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116 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY TABLE B.1 Description and Outcomes of Included Studies (NVP arms only) Author, Study, Study Population Infants Infected and Reference Randomized Study Arms Antepartum (%)
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APPENDIX B 117 Infants Infected Total Infant HIV Intrapartum and Infections By Infant Serious Early Postpartum (%) 68 Weeks (%)
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118 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY the regimen that had been evaluated in the Promoting Evaluation, Teaching, and Research on AIDS Project (PETRA) study.
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APPENDIX B 119 Outcomes The proportion of infants in the NVP arm infected with HIV in HIVNET 012 was 8.1% at birth, 11.7% at 68 weeks, 13.3% at 1416 weeks, 14.9% at 12 months, and 15.3% at 18 months of age (4)
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120 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY Description of Excluded Studies Three randomized controlled trials were excluded because they either combined NVP with other antiretrovirals (13-18) or included multiple doses of NVP postnatally (19)
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121 reported reported study (%) difference to adverse Events (33%)
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122 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY TABLE B.3 Description and Outcomes of Included Studies (ZDV arms only) Author, Study Study Population and Reference Randomized Study Arms Dabis (1999)
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APPENDIX B 123 Infants Infected Infants Infected Intrapartum and Antepartum (%) Early Postpartum (%)
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124 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY Outcomes The proportion of infants in the zidovudine arm infected with HIV in HIVNET 012 was 10.3% at birth, 19.5% at 68 weeks, 21.5% at 1416 weeks, 23.2% at 12 months, and 24.8% at 18 months of age (4)
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APPENDIX B 125 TABLE B.4 Excluded Studies (ZDV-only arms) Study Author, Study Population Reason for and Reference Randomized Study Arms Exclusion Bordeguez PACTG 288 -- Ante-, intra-, and Follow-on study of (2003)
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126 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY was lower (6.0%) and thus more similar to the HIVNET 012 results.
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APPENDIX B 127 and adverse events when the HIVNET 012 NVP regimen has been employed. For example, Stringer and colleagues have followed two observational cohort studies of HIV-exposed infants who received single-dose NVP and whose mothers received intrapartum NVP in Zambia (26-27)
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128 REVIEW OF THE HIVNET 012 PERINATAL HIV PREVENTION STUDY 8. Moodley D, Moodley J, Coovadia H, et al.
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APPENDIX B 129 22. Shaffer N, Chuachoowong R, Mock PA, et al.
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