drugset / Trial / NCT00115648
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Phase 3
Completed
3300 enrolled
Johns Hopkins Bloomberg School of Public Health
Centers for Disease Control and Prevention · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupOpen-labelPrevention
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZT | Unknown | — | Oral |
| Subject | Nevirapine | Small molecule | — | Oral |