title: Effect of cessation of zidovudine prophylaxis to reduce vertical transmission on maternal HIV disease progression and survival.
abstract: Zidovudine prophylaxis is recommended to reduce perinatal HIV-1 transmission, but there are limited data on long-term effects on women's health. Pediatrics AIDS Clinical Trials Group (PACTG) 288 was a prospective observational study among US women randomized to zidovudine or placebo in PACTG 076 that was designed to evaluate and compare postpartum clinical, immune, and viral parameters between randomized treatment arms. Forty-eight percent (226/474) of eligible women enrolled in the study (mean follow-up of 4.1 years). Progression and time to AIDS or death were similar in both groups, observed in 21 (19%) zidovudine group women and 29 (25%) placebo group women (RR = 0.73, 90% CI: 0.46-1.17). No significant differences in CD4 lymphocyte count or HIV RNA levels were detected. Genotypic zidovudine resistance was detected in 10% of 156 women (9% of zidovudine group women and 11% of placebo group women). Based on our data, ZDV monotherapy could be considered as chemoprophylaxis to reduce perinatal HIV transmission for minimally symptomatic HIV-infected pregnant women with a low viral load and normal CD4 cell count who do not want to receive highly active antiretroviral therapy because of concern about potential side effects or who wish to reduce fetal exposure to multiple drugs during pregnancy.
authors.affiliation: University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07103, USA. bardegad@umdnj.edu
authors.forename: Arlene D
authors.initials: AD
authors.lastname: Bardeguez
authors.forename: David E
authors.initials: DE
authors.lastname: Shapiro
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.forename: Robert
authors.initials: R
authors.lastname: Coombs
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Frenkel
authors.forename: Mary Glenn
authors.initials: MG
authors.lastname: Fowler
authors.forename: Sharon
authors.initials: S
authors.lastname: Huang
authors.forename: Rhoda S
authors.initials: RS
authors.lastname: Sperling
authors.forename: Bethann
authors.initials: B
authors.lastname: Cunningham
authors.forename: Jorge
authors.initials: J
authors.lastname: Gandia
authors.forename: Robert
authors.initials: R
authors.lastname: Maupin
authors.forename: Carmen D
authors.initials: CD
authors.lastname: Zorrilla
authors.forename: Theodore
authors.initials: T
authors.lastname: Jones
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: O'Sullivan
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy / Q000635:transmission*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000276:immunology / Q000517:prevention & control*; D011256:Pregnancy Outcome; D012367:RNA, Viral / Q000097:blood; D016019:Survival Analysis; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine