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Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.


ABSTRACT: Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4? cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda.Randomized clinical trial.We performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA ?400 copies/ml), safety, and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir versus efavirenz-based ART would reduce placental malaria (PROMOTE, ClinicalTrials.gov, NCT00993031). HIV-infected, ART-naive pregnant women at 12-28 weeks gestation and any CD4? cell count were randomized. ART was provided and participants were counseled to breastfeed for 1 year postpartum.The median age of the 389 study participants was 29 years; median CD4? cell count was 370 cells/?l. At delivery, virologic suppression was 97.6% in the efavirenz arm and 86.0% in the lopinavir/ritonavir arm (P?

SUBMITTER: Cohan D 

PROVIDER: S-EPMC4428759 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.

Cohan Deborah D   Natureeba Paul P   Koss Catherine A CA   Plenty Albert A   Luwedde Flavia F   Mwesigwa Julia J   Ades Veronica V   Charlebois Edwin D ED   Gandhi Monica M   Clark Tamara D TD   Nzarubara Bridget B   Achan Jane J   Ruel Theodore T   Kamya Moses R MR   Havlir Diane V DV  

AIDS (London, England) 20150101 2


<h4>Objective</h4>Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4⁺ cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda.<h4>Design</h4>Randomized clinical trial.<h4>Methods</h4>We performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA ≤400 copies/ml), safety, and HIV transmission  ...[more]

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