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Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study
R S Sperling1, D E Shapiro, G D McSherry
1Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai School of Medicine, New York, New York, USA.
Insights
The zidovudine (ZDV) regimen used in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study was safe for preventing mother-to-child HIV-1 transmission. No significant adverse effects were observed in mothers or infants, supporting its continued use.
Area of Science:
- Pediatric HIV/AIDS research
- Antiviral therapy safety
- Maternal-fetal medicine
Background:
- The Pediatric AIDS Clinical Trial Group (ACTG) 076 study established zidovudine (ZDV) as effective in preventing mother-to-child HIV-1 transmission.
- Safety data for the ZDV regimen in this context required thorough evaluation.
Purpose of the Study:
- To assess the safety profile of the zidovudine (ZDV) regimen used in the ACTG 076 trial.
- To identify any potential adverse effects in mothers and infants associated with ZDV treatment.
Main Methods:
- A randomized, double-blind, placebo-controlled trial design (ACTG 076).
- Prospective monitoring of maternal complications, pregnancy outcomes, infant growth and development, and maternal HIV-1 disease progression.
- Follow-up of infants through 18 months and mothers through 6 months postpartum.
Main Results:
- Maternal ZDV therapy was well-tolerated with no serious adverse pregnancy outcomes.
- Infant ZDV exposure was associated with a risk of anemia in the first six weeks, independent of other factors.
- No increased incidence of newborn structural abnormalities or differences in infant growth and immune function at 18 months.
- No significant differences in maternal clinical, immunologic, or virologic disease progression at 6 months postpartum.
Conclusions:
- The zidovudine (ZDV) regimen demonstrated an acceptable safety profile.
- No safety concerns were identified that would warrant altering current recommendations for ZDV use in preventing mother-to-child HIV-1 transmission.
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.