P1081 was a phase IV open-label randomized study of HIV-1 infected pregnant women who are ARV-naïve (except for ARVs for PMTCT in previous pregnancies) between 28 and 36 weeks gestation and their infants. Women are randomized to one of three different triple ARV regimens:
Main Objectives:
Pour plus d'information: IMPAACT Study P1081
- Arm A: lamivudine/zidovudine + lopinavir/ritonavir
- Arm B: lamivudine/zidovudine + efavirenz
- Arm C: lamivudine/zidovudine + raltegravir
Main Objectives:
- To compare the ability to achieve both (a) a rapid viral load decrease (by week 2) which is sustained until delivery and (b) tolerability through delivery of three different triple ARV regimens (containing lopinavir/ritonavir, efavirenz or raltegravir) in pregnant women initiating triple ARV regimens between 28 and 36 weeks of gestation for PMTCT.
- To evaluate the safety of the three regimens including adverse events that may occur while on study drug or during maternal and infant follow-up.
Pour plus d'information: IMPAACT Study P1081