Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

Summary

The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.

Timeline

Start

2004-04

Primary completion

2007-08

Completion

2009-10

Outcome

Met primary endpoint

paper the primary end point) was 10.6% in the control group, as compared with 5.2% in the extended-nevirapine group (P<0.001) PMID 18525035 ↗

Publications

• Schwartz SR, Kumwenda N, Kumwenda J, Chen S, Mofenson LM, Taylor AW, Fowler MG, Taha TE. Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009. Matern Child Health J. 2016 Mar;20(3):542-9. doi: 10.1007/s10995-015-1852-5.
• Redd AD, Wendel SK, Longosz AF, Fogel JM, Dadabhai S, Kumwenda N, Sun J, Walker MP, Bruno D, Martens C, Eshleman SH, Porcella SF, Quinn TC, Taha TE. Evaluation of postpartum HIV superinfection and mother-to-child transmission. AIDS. 2015 Jul 31;29(12):1567-73. doi: 10.1097/QAD.0000000000000740.
• Taha TE, Li Q, Hoover DR, Mipando L, Nkanaunena K, Thigpen MC, Taylor A, Kumwenda J, Fowler MG, Mofenson LM, Kumwenda NI. Postexposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi trial. J Acquir Immune Defic Syndr. 2011 Aug 1;57(4):319-25. doi: 10.1097/QAI.0b013e318217877a.
• Kumwenda NI, Hoover DR, Mofenson LM, Thigpen MC, Kafulafula G, Li Q, Mipando L, Nkanaunena K, Mebrahtu T, Bulterys M, Fowler MG, Taha TE. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med. 2008 Jul 10;359(2):119-29. doi: 10.1056/NEJMoa0801941. Epub 2008 Jun 4.

Drugs

Indications