Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies

Summary

To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safety, tolerability, and blood levels of TDF in HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi and Brazil.

Timeline

Start

2006-11

Primary completion

2011-10

Completion

2011-12

Publications

• Background Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
• Background Capparelli E, Rakhmanina N, Mirochnick M. Pharmacotherapy of perinatal HIV. Semin Fetal Neonatal Med. 2005 Apr;10(2):161-75. doi: 10.1016/j.siny.2004.10.001. Epub 2005 Jan 20.
• Background Thorne C, Newell ML. Mother-to-child transmission of HIV infection and its prevention. Curr HIV Res. 2003 Oct;1(4):447-62. doi: 10.2174/1570162033485140.
• Background Capparelli EV, Englund JA, Connor JD, Spector SA, McKinney RE, Palumbo P, Baker CJ. Population pharmacokinetics and pharmacodynamics of zidovudine in HIV-infected infants and children. J Clin Pharmacol. 2003 Feb;43(2):133-40. doi: 10.1177/0091270002239821.
• Osorio LE, Boechat MI, Mirochnick M, Kumwenda N, Kreitchmann R, Emel L, Pinto J, Joao E, Santos B, Swenson M, George K, Sato P, Mofenson L, Nielsen-Saines K; HIV Prevention Trials Network (HPTN) 057 Protocol Team. Bone Age and Mineral Density Assessments Using Plain Roentgenograms in Tenofovir-exposed Infants in Malawi and Brazil Enrolled in HIV Prevention Trials Network 057. Pediatr Infect Dis J. 2017 Feb;36(2):184-188. doi: 10.1097/INF.0000000000001386.

Drugs

Indications