Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study.
OBJECTIVE
To determine the safety of the zidovudine (ZDV) regimen utilized in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study.


METHODS
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.


CONCLUSIONS
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.
Sperling
R S
RS
Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai School of Medicine, New York, New York, USA.
Shapiro
D E
DE
McSherry
G D
GD
Britto
P
P
Cunningham
B E
BE
Culnane
M
M
Coombs
R W
RW
Scott
G
G
Van Dyke
R B
RB
Shearer
W T
WT
Jimenez
E
E
Diaz
C
C
Harrison
D D
DD
Delfraissy
J F
JF
D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005602:France; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission*; D015497:HIV-1; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome; D014481:United States; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D015215:Zidovudine