title: Risk factors for preterm birth among HIV-infected pregnant Ugandan women randomized to lopinavir/ritonavir- or efavirenz-based antiretroviral therapy.
abstract: BACKGROUND
  Protease inhibitor-based antiretroviral therapy (ART) has been associated with preterm birth in some studies. We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir (LPV/r)- or efavirenz (EFV)-based ART.
  
  
  METHODS
  This was a planned secondary analysis of the PROMOTE-Pregnant Women and Infants Study, an open-label, randomized controlled trial comparing the risk of placental malaria among HIV-infected, ART-naive pregnant Ugandan women assigned to initiate LPV/r- or EFV-based ART at 12-28 weeks gestation. Gestational age was determined based on last menstrual period and ultrasound biometry. All women received bednets and trimethoprim-sulfamethoxazole. Stillbirths, spontaneous abortions, and multiple gestations were excluded from the primary analysis. Potential risk factors for preterm birth (<37 weeks gestation) were evaluated by univariate and multivariate logistic regression.
  
  
  RESULTS
  Three hundred fifty-six women were included in this analysis. At enrollment, median gestational age was 21 weeks and median CD4 cell count was 368 cells per cubic millimeter. 14.7% of deliveries in the EFV arm and 16.2% in the LPV/r arm were preterm. Preterm birth was associated with gestational weight gain below 0.1 kg/week versus 0.1 kg/week or more [odds ratio (OR) = 2.49; 95% confidence interval (CI): 1.38 to 4.47; P = 0.003]. Neither ART regimen of LPV/r versus EFV (OR = 1.12; 95% CI: 0.63 to 2.00; P = 0.69) nor placental malaria (OR = 0.74; 95% CI: 0.38 to 1.44; P = 0.37) was associated with preterm birth.
  
  
  CONCLUSIONS
  LPV/r was not associated with an increased risk of preterm birth compared with EFV. However, interventions are needed to address modifiable risk factors for preterm birth, such as nutritional status (ClinicalTrials.gov, NCT00993031).
authors: *HIV/AIDS Division, Department of Medicine, San Francisco General Hospital, University of California, San Francisco, San Francisco, CA; †Makerere University-University of California, San Francisco Research Collaboration, Kampala, Uganda; ‡Center for AIDS Prevention Studies, Department of Medicine, University of California, San Francisco, San Francisco, CA; §Department of Obstetrics and Gynecology, New York University, New York, NY; ‖Medical Research Council Unit, The Gambia; ¶Division of Infectious Diseases, Department of Pediatrics, University of California, San Francisco, San Francisco, CA; #Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda; and **Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.
authors: Catherine A
authors: CA
authors: Koss
authors: Paul
authors: P
authors: Natureeba
authors: Albert
authors: A
authors: Plenty
authors: Flavia
authors: F
authors: Luwedde
authors: Julia
authors: J
authors: Mwesigwa
authors: Veronica
authors: V
authors: Ades
authors: Edwin D
authors: ED
authors: Charlebois
authors: Tamara D
authors: TD
authors: Clark
authors: Jane
authors: J
authors: Achan
authors: Theodore
authors: T
authors: Ruel
authors: Bridget
authors: B
authors: Nzarubara
authors: Moses R
authors: MR
authors: Kamya
authors: Diane V
authors: DV
authors: Havlir
authors: Deborah
authors: D
authors: Cohan
mesh_terms: D000293:Adolescent; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects* / Q000379:methods*; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D061466:Lopinavir / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D011247:Pregnancy; D047928:Premature Birth / Q000453:epidemiology*; D012307:Risk Factors; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use; D014454:Uganda / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D061466:Lopinavir; C098320:efavirenz; D019438:Ritonavir