Lopinavir/ritonavir-based antiretroviral treatment (ART) versus efavirenz-based ART for the prevention of malaria among HIV-infected pregnant women

J Infect Dis. 2014 Dec 15;210(12):1938-45. doi: 10.1093/infdis/jiu346. Epub 2014 Jun 23.


Background: Human immunodeficiency virus (HIV)-infected pregnant women are at increased risk of malaria and its complications. In vitro and in vivo data suggest that the HIV protease inhibitors lopinavir/ritonavir may have potent antimalarial activity. We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy (ART) reduced the risk of placental malaria.

Methods: HIV-infected, ART-naive pregnant women were enrolled between gestational weeks 12 and 28 and randomly assigned to receive lopinavir/ritonavir-based or efavirenz-based ART. Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bed nets at enrollment and were followed up to 1 year after delivery. The primary outcome was placental malaria, defined by the detection of malaria parasites, using microscopy or polymerase chain reaction (PCR) analysis of placental blood specimens. Secondary outcomes included placental malaria, defined by histopathologic results; adverse birth outcomes; incidence of malaria; and prevalence of asymptomatic parasitemia. Analyses were done using an intention-to-treat approach.

Results: Of 389 subjects randomly assigned to a treatment group, 377 were followed through to delivery. There was no significant difference in the risk of placental malaria, as defined by thick smear or PCR findings, between the lopinavir/ritonavir-based and efavirenz-based ART arms (7.4% vs 9.8%; P = .45). Similarly, there were no differences in secondary outcomes between the 2 treatment arms.

Conclusions: Lopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes, compared with efavirenz-based ART.

Clinical trials registration: NCT00993031.

Keywords: HIV; efavirenz; lopinavir/ritonavir; malaria; pregnancy.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Alkynes
  • Anti-HIV Agents / therapeutic use*
  • Antimalarials / therapeutic use*
  • Antiretroviral Therapy, Highly Active / methods*
  • Benzoxazines / therapeutic use
  • Cyclopropanes
  • Female
  • HIV Infections / complications*
  • HIV Infections / drug therapy*
  • Humans
  • Infant, Newborn
  • Lopinavir / therapeutic use
  • Malaria / prevention & control*
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy
  • Pregnancy Complications, Infectious / prevention & control
  • Ritonavir / therapeutic use
  • Treatment Outcome
  • Trimethoprim, Sulfamethoxazole Drug Combination / therapeutic use
  • Young Adult


  • Alkynes
  • Anti-HIV Agents
  • Antimalarials
  • Benzoxazines
  • Cyclopropanes
  • Lopinavir
  • Trimethoprim, Sulfamethoxazole Drug Combination
  • efavirenz
  • Ritonavir

Associated data

  • ClinicalTrials.gov/NCT00993031