A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and their Infants
What was HPTN 057?
A Phase I, open label, non-controlled trial to evaluate the safety and pharmacokinetics of tenofovir disoproxil fumarate (TDF) when administered to HIV infected pregnant women during labor and to their infants during the first week of life to determine the optimal regimen for a subsequent efficacy trial, if indicated.
Who participated in the study?
Mothers: HIV-1 infected pregnant women; Infants: born to HIV-1 infected enrolled mothers (110 fully evaluable mother/infant pairs)
What happened during the study?
Eligible women and their infants were enrolled in one of four cohorts:
Cohort 1: Mothers received a single 600 mg oral dose of TDF at onset of labor; infants were not dosed.
Cohort 2: Mothers were not dosed; infants receivde 4 mg/kg of the TDF oral suspension at birth (within 12 hours) and on Days 3 and 5 of life.
Cohort 3: Mothers received a single 900 mg oral dose of TDF at onset of labor and infants received 6 mg/kg of the TDF oral suspension at birth (within 12 hours) and on Days 3 and 5 of life.
Cohort 4: Mothers received a single 600 mg oral dose of TDF at onset of labor and infants received 6 mg/kg of the TDF oral suspension daily for 7 days initiated at birth.
Why was this study important?
HPTN 057 provided the pharmacokinetic and safety data needed to design a tenofovir regimen that can be used in trials to evaluate the efficacy of tenofovir in prevention of mother-to-child HIV