Maternal baseline in A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Triple Antiretroviral Regimens in HIV Infected Women Initiated Between 28 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission

Maternal demographics and characteristics prior to or at the time of randomization, including age, race/ethnicity, HIV viral load, CD4 count, and antiretroviral drug regimen
Study Description
P1081 was a Phase IV multicenter, randomized, open-label trial comparing the virologic response, safety, and tolerability of raltegravir. The study population included Human Immunodeficiency Virus (HIV)-1 infected pregnant women with a gestational age between 28 and 36 weeks who are antiretroviral (ARV) naïve or have received short-course zidovudine only for prevention of mother-to-child transmission in previous pregnancies, and their infants. The primary objectives were to compare the ability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy to achieve a viral load of < 200 copies/mL at the time of delivery and compare the safety and tolerability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy. All women received a randomized regimen from study entry through delivery. The study showed both regimens to be safe and well-tolerated. The rate of suppression at delivery was found to be higher with raltegravir, primarily with those enrolling in the third trimester. Pregnancy outcomes in this study were consistent with previous studies of initiation of other antiretroviral regimens in pregnancy. While the HIV perinatal transmission rate was not significantly different between treatment arms in our study, substantially fewer infants were infected in the raltegravir arm compared to the efavirenz arm. The results of this study support the use of raltegravir in pregnant women who present late for care. HIV-infected pregnant women with a gestational age between 28 and 36 weeks were randomly assigned to one of two arms