HPTN 040/P1043 NFV/3TC Pharmacokinetic Substudy Samples Dataset in Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens For Prevention Of Intrapartum HIV-1 Transmission

Timing of Nelfinavir (NFV) and Lamivudine (3TC) pharmacokinetic collections or reason not collected (NFV/3TC Pharmacokinetic Substudy CRF)
Study Description
Compared the efficacy and safety of three antiretroviral regimens [standard zidovudine (ZDV) regimen vs. ZDV and nevirapine (NVP) vs. ZDV, lamivudine (3TC) and nelfinavir (NFV)] administered for the prevention of vertical HIV-1 transmission to infants born to HIV-1-infected women who did not receive antiretroviral therapy during the current pregnancy. Primary outcome measure was HIV-1 infection at 3 months in infants uninfected at birth. This study was conducted by the National Institute of Allergy and Infectious Diseases (NIAID) HIV Prevention Trials Network (HPTN). Biospecimens are available. HIV positive women (n=1724) in Argentina, Brazil, South Africa, and the U.S. who did not receive antiretroviral therapy during pregnancy and their newborn infants (n=1745); race and ethnicity data below are for mothers only