title: Safety and efficacy of HIV hyperimmune globulin for prevention of mother-to-child HIV transmission in HIV-1-infected pregnant women and their infants in Kampala, Uganda (HIVIGLOB/NVP STUDY).
abstract: BACKGROUND
  This phase III, randomized, clinical trial compared single-dose nevirapine (sdNVP) plus HIV hyperimmune globulin (HIVIGLOB) with sdNVP alone for preventing maternal-to-child transmission of HIV. Primary objectives were to determine rates of HIV infection among infants and to assess the safety of HIVIGLOB in combination with sdNVP in HIV-infected Ugandan pregnant women and their infants.
  
  
  METHODS
  Mother-infant pairs were randomized to receive 200 mg of nevirapine to women in labor and 2 mg/kg NVP to newborns within 72 hours after birth (sdNVP arm) or to receive sdNVP plus a single intravenous 240-mL dose of HIVIGLOB given to women at 36- to 38-week gestation and a single intravenous 24-mL dose to newborns within 18 hours of birth (HIVIGLOB/sdNVP arm). Risk of HIV infection was determined using Kaplan-Meier and risk ratio estimates at birth, 2, 6, 14 weeks, 6, and 12 months of age.
  
  
  RESULTS
  Intent-to-treat analysis included 198 HIVIGLOB/sdNVP and 294 sdNVP mother-infant pairs. At 6 months of age, the primary endpoint, there was no statistically significant difference in HIV transmission in the HIVIGLOB/sdNVP arm vs. the sdNVP arm [18.7% vs. 15.0%; risk ratio = 1.240 (95% confidence interval: 0.833 to 1.846); P = 0.290]. Similarly, the proportion of serious adverse events in the HIVIGLOB/sdNVP and sdNVP arms, respectively, for mothers (18.9% vs. 19.3%; P = 0.91) and infants (62.6% vs. 59.5%; P = 0.51) was not significantly different.
  
  
  CONCLUSIONS
  Giving mother-infant pairs an infusion of peripartum HIV hyperimmune globulin in addition to sdNVP for preventing maternal-to-child transmission was as safe as sdNVP alone but was no more effective than sdNVP alone in preventing HIV transmission.
authors.affiliation: Makerere University, Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda. carolonyango@mujhu.org
authors.forename: Carolyne
authors.initials: C
authors.lastname: Onyango-Makumbi
authors.forename: Saad B
authors.initials: SB
authors.lastname: Omer
authors.forename: Michael
authors.initials: M
authors.lastname: Mubiru
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Moulton
authors.forename: Clemensia
authors.initials: C
authors.lastname: Nakabiito
authors.forename: Philippa
authors.initials: P
authors.lastname: Musoke
authors.forename: Francis
authors.initials: F
authors.lastname: Mmiro
authors.forename: Sheryl
authors.initials: S
authors.lastname: Zwerski
authors.forename: Hans
authors.initials: H
authors.lastname: Wigzell
authors.forename: Lars
authors.initials: L
authors.lastname: Falksveden
authors.forename: Britta
authors.initials: B
authors.lastname: Wahren
authors.forename: Gretchen
authors.initials: G
authors.lastname: Antelman
authors.forename: Mary Glenn
authors.initials: MG
authors.lastname: Fowler
authors.forename: Laura
authors.initials: L
authors.lastname: Guay
authors.forename: J Brooks
authors.initials: JB
authors.lastname: Jackson
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control* / Q000706:statistics & numerical data; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000517:prevention & control; D014454:Uganda / Q000453:epidemiology; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; C084715:HIV hyperimmune globulin; D016756:Immunoglobulins, Intravenous; D019829:Nevirapine