Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study

Rhoda S. Sperling, David E. Shapiro, George McSherry, Paula Britto, Bethann E. Cunningham, Mary Culnane, Robert W. Coombs, Gwendolyn Scott, Russell B. Van Dyke, William T. Shearer, Eleanor Jimenez, Clemente Diaz, Duane D. Harrison, Jean Francois Delfraissy

Research output: Contribution to journalArticle

124 Citations (Scopus)

Abstract

Objective: To determine the safety of the zidovudine (ZDV) regimen utilized in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study. Design: ACTG 076 was a randomized, double-blind, placebo-controlled trial which demonstrated that a ZDV regimen could prevent mother-to-child HIV-1 transmission. Infants were followed through 18 months of age and women were followed through 6 months postpartum. Methods: Maternal complications, pregnancy outcomes, growth and development of the uninfected infants, and HIV-1 disease progression in the women were monitored prospectively. Results: Maternal therapy was well tolerated. There was no serious pattern of adverse pregnancy outcomes associated with ZDV use. Amongst the ZDV-exposed infants, the only recognized toxicity was anemia within the first 6 weeks of life; the risk for anemia was not associated with premature delivery, duration of maternal treatment, degree of maternal immunosuppression, or maternal anemia. ZDV treatment was not associated with an increased incidence of newborn structural abnormalities. At 18 months of age, uninfected infants did not differ in growth parameters or immune function. No childhood neoplasias were reported in either group. In the women, at 6 months postpartum, there were no differences in clinical, immunologic, or virologic disease progression. Conclusion: There were no identified problems that would alter current recommendations for the routine use of ZDV for the prevention of mother-child HIV-1 transmission.

Original languageEnglish (US)
Pages (from-to)1805-1813
Number of pages9
JournalAIDS
Volume12
Issue number14
DOIs
StatePublished - Oct 1 1998

Fingerprint

Zidovudine
Acquired Immunodeficiency Syndrome
Mothers
Clinical Trials
Pediatrics
Safety
HIV-1
Anemia
Pregnancy Outcome
Postpartum Period
Disease Progression
Growth and Development
Immunosuppression
Therapeutics
Placebos
Newborn Infant
Incidence
Growth
Neoplasms

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

Sperling, R. S., Shapiro, D. E., McSherry, G., Britto, P., Cunningham, B. E., Culnane, M., ... Delfraissy, J. F. (1998). Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study. AIDS, 12(14), 1805-1813. https://doi.org/10.1097/00002030-199814000-00012
Sperling, Rhoda S. ; Shapiro, David E. ; McSherry, George ; Britto, Paula ; Cunningham, Bethann E. ; Culnane, Mary ; Coombs, Robert W. ; Scott, Gwendolyn ; Van Dyke, Russell B. ; Shearer, William T. ; Jimenez, Eleanor ; Diaz, Clemente ; Harrison, Duane D. ; Delfraissy, Jean Francois. / Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study. In: AIDS. 1998 ; Vol. 12, No. 14. pp. 1805-1813.
@article{8f6f2d7dcc03489cb2b5026c56b3b51b,
title = "Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study",
abstract = "Objective: To determine the safety of the zidovudine (ZDV) regimen utilized in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study. Design: ACTG 076 was a randomized, double-blind, placebo-controlled trial which demonstrated that a ZDV regimen could prevent mother-to-child HIV-1 transmission. Infants were followed through 18 months of age and women were followed through 6 months postpartum. Methods: Maternal complications, pregnancy outcomes, growth and development of the uninfected infants, and HIV-1 disease progression in the women were monitored prospectively. Results: Maternal therapy was well tolerated. There was no serious pattern of adverse pregnancy outcomes associated with ZDV use. Amongst the ZDV-exposed infants, the only recognized toxicity was anemia within the first 6 weeks of life; the risk for anemia was not associated with premature delivery, duration of maternal treatment, degree of maternal immunosuppression, or maternal anemia. ZDV treatment was not associated with an increased incidence of newborn structural abnormalities. At 18 months of age, uninfected infants did not differ in growth parameters or immune function. No childhood neoplasias were reported in either group. In the women, at 6 months postpartum, there were no differences in clinical, immunologic, or virologic disease progression. Conclusion: There were no identified problems that would alter current recommendations for the routine use of ZDV for the prevention of mother-child HIV-1 transmission.",
author = "Sperling, {Rhoda S.} and Shapiro, {David E.} and George McSherry and Paula Britto and Cunningham, {Bethann E.} and Mary Culnane and Coombs, {Robert W.} and Gwendolyn Scott and {Van Dyke}, {Russell B.} and Shearer, {William T.} and Eleanor Jimenez and Clemente Diaz and Harrison, {Duane D.} and Delfraissy, {Jean Francois}",
year = "1998",
month = "10",
day = "1",
doi = "10.1097/00002030-199814000-00012",
language = "English (US)",
volume = "12",
pages = "1805--1813",
journal = "AIDS",
issn = "0269-9370",
publisher = "Lippincott Williams and Wilkins",
number = "14",

}

Sperling, RS, Shapiro, DE, McSherry, G, Britto, P, Cunningham, BE, Culnane, M, Coombs, RW, Scott, G, Van Dyke, RB, Shearer, WT, Jimenez, E, Diaz, C, Harrison, DD & Delfraissy, JF 1998, 'Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study', AIDS, vol. 12, no. 14, pp. 1805-1813. https://doi.org/10.1097/00002030-199814000-00012

Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study. / Sperling, Rhoda S.; Shapiro, David E.; McSherry, George; Britto, Paula; Cunningham, Bethann E.; Culnane, Mary; Coombs, Robert W.; Scott, Gwendolyn; Van Dyke, Russell B.; Shearer, William T.; Jimenez, Eleanor; Diaz, Clemente; Harrison, Duane D.; Delfraissy, Jean Francois.

In: AIDS, Vol. 12, No. 14, 01.10.1998, p. 1805-1813.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 study

AU - Sperling, Rhoda S.

AU - Shapiro, David E.

AU - McSherry, George

AU - Britto, Paula

AU - Cunningham, Bethann E.

AU - Culnane, Mary

AU - Coombs, Robert W.

AU - Scott, Gwendolyn

AU - Van Dyke, Russell B.

AU - Shearer, William T.

AU - Jimenez, Eleanor

AU - Diaz, Clemente

AU - Harrison, Duane D.

AU - Delfraissy, Jean Francois

PY - 1998/10/1

Y1 - 1998/10/1

N2 - Objective: To determine the safety of the zidovudine (ZDV) regimen utilized in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study. Design: ACTG 076 was a randomized, double-blind, placebo-controlled trial which demonstrated that a ZDV regimen could prevent mother-to-child HIV-1 transmission. Infants were followed through 18 months of age and women were followed through 6 months postpartum. Methods: Maternal complications, pregnancy outcomes, growth and development of the uninfected infants, and HIV-1 disease progression in the women were monitored prospectively. Results: Maternal therapy was well tolerated. There was no serious pattern of adverse pregnancy outcomes associated with ZDV use. Amongst the ZDV-exposed infants, the only recognized toxicity was anemia within the first 6 weeks of life; the risk for anemia was not associated with premature delivery, duration of maternal treatment, degree of maternal immunosuppression, or maternal anemia. ZDV treatment was not associated with an increased incidence of newborn structural abnormalities. At 18 months of age, uninfected infants did not differ in growth parameters or immune function. No childhood neoplasias were reported in either group. In the women, at 6 months postpartum, there were no differences in clinical, immunologic, or virologic disease progression. Conclusion: There were no identified problems that would alter current recommendations for the routine use of ZDV for the prevention of mother-child HIV-1 transmission.

AB - Objective: To determine the safety of the zidovudine (ZDV) regimen utilized in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study. Design: ACTG 076 was a randomized, double-blind, placebo-controlled trial which demonstrated that a ZDV regimen could prevent mother-to-child HIV-1 transmission. Infants were followed through 18 months of age and women were followed through 6 months postpartum. Methods: Maternal complications, pregnancy outcomes, growth and development of the uninfected infants, and HIV-1 disease progression in the women were monitored prospectively. Results: Maternal therapy was well tolerated. There was no serious pattern of adverse pregnancy outcomes associated with ZDV use. Amongst the ZDV-exposed infants, the only recognized toxicity was anemia within the first 6 weeks of life; the risk for anemia was not associated with premature delivery, duration of maternal treatment, degree of maternal immunosuppression, or maternal anemia. ZDV treatment was not associated with an increased incidence of newborn structural abnormalities. At 18 months of age, uninfected infants did not differ in growth parameters or immune function. No childhood neoplasias were reported in either group. In the women, at 6 months postpartum, there were no differences in clinical, immunologic, or virologic disease progression. Conclusion: There were no identified problems that would alter current recommendations for the routine use of ZDV for the prevention of mother-child HIV-1 transmission.

UR - http://www.scopus.com/inward/record.url?scp=7344221468&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=7344221468&partnerID=8YFLogxK

U2 - 10.1097/00002030-199814000-00012

DO - 10.1097/00002030-199814000-00012

M3 - Article

C2 - 9792381

AN - SCOPUS:7344221468

VL - 12

SP - 1805

EP - 1813

JO - AIDS

JF - AIDS

SN - 0269-9370

IS - 14

ER -