title: Lopinavir/ritonavir-based antiretroviral treatment (ART) versus efavirenz-based ART for the prevention of malaria among HIV-infected pregnant women.
abstract: 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.
  
  
  BACKGROUND
  NCT00993031.
authors: Infectious Diseases Research Collaboration.
authors: Paul
authors: P
authors: Natureeba
authors: Department of Obstetrics and Gynecology, New York University, New York City.
authors: Veronica
authors: V
authors: Ades
authors: Infectious Diseases Research Collaboration.
authors: Flavia
authors: F
authors: Luwedde
authors: Infectious Diseases Research Collaboration.
authors: Julia
authors: J
authors: Mwesigwa
authors: Department of Medicine.
authors: Albert
authors: A
authors: Plenty
authors: Ugandan Ministry of Health.
authors: Pius
authors: P
authors: Okong
authors: Department of Medicine.
authors: Edwin D
authors: ED
authors: Charlebois
authors: Department of Medicine.
authors: Tamara D
authors: TD
authors: Clark
authors: Infectious Diseases Research Collaboration.
authors: Bridget
authors: B
authors: Nzarubara
authors: Department of Medicine.
authors: Diane V
authors: DV
authors: Havlir
authors: Department of Pediatrics.
authors: Jane
authors: J
authors: Achan
authors: Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
authors: Moses R
authors: MR
authors: Kamya
authors: Department of Obstetrics and Gynecology, University of California-San Francisco.
authors: Deborah
authors: D
authors: Cohan
authors: Department of Medicine.
authors: Grant
authors: G
authors: Dorsey
mesh_terms: D000293:Adolescent; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000962:Antimalarials / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D048588:Benzoxazines / Q000627:therapeutic use; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D061466:Lopinavir / Q000627:therapeutic use; D008288:Malaria / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000517:prevention & control; D019438:Ritonavir / Q000627:therapeutic use; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D000962:Antimalarials; D048588:Benzoxazines; D003521:Cyclopropanes; D061466:Lopinavir; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; C098320:efavirenz; D019438:Ritonavir
keywords: HIV; efavirenz; lopinavir/ritonavir; malaria; pregnancy