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Volume 343:982-991 October 5, 2000 Number 14 Next

	Full Text PDF Editorial by Peckham, C. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background The optimal duration of zidovudine administration to prevent perinatal transmission of human immunodeficiency virus type 1 (HIV-1) should be determined to facilitate its use in areas where resources are limited.

Methods We conducted a randomized, double-blind equivalence trial of four regimens of zidovudine starting in the mother at 28 weeks' gestation, with 6 weeks of treatment in the infant (the long–long regimen), which is similar to protocol 076; zidovudine starting at 35 weeks' gestation, with 3 days of treatment in the infant (the short–short regimen); a long–short regimen; and a short–long regimen. The mothers received zidovudine orally during labor. The infants were fed formula and were tested for HIV DNA at 1, 45, 120, and 180 days. After the first interim analysis, the short–short regimen was stopped.

Results A total of 1437 women were enrolled. At the first interim analysis, the rates of HIV transmission were 4.1 percent for the long–long regimen and 10.5 percent for the short–short regimen (P=0.004); at this point the short–short regimen was stopped. For the entire study period, the transmission rates were 6.5 percent (95 percent confidence interval, 4.1 to 8.9 percent) for the long–long regimen, 4.7 percent (95 percent confidence interval, 2.4 to 7.0 percent) for the long–short regimen, and 8.6 percent (95 percent confidence interval, 5.6 to 11.6 percent) for the short–long regimen. The rate of in utero transmission was significantly higher with the two regimens with shorter maternal treatment (5.1 percent) than with the two with longer maternal treatment (1.6 percent).

Conclusions The short–short zidovudine regimen is inferior to the long–long regimen and leads to a higher rate of perinatal HIV transmission. The long–short, short–long, and long–long regimens had equivalent efficacy. However, the higher rate of in utero transmission with the short–long regimen suggests that longer treatment of the infant cannot substitute for longer treatment of the mother.

Source Information

From Epidémiologie Clinique, Santé Maternelle et Infantile et Sida, Institut de Recherche pour le Développement, Paris (M.L., G.J.); the Departments of Immunology and Infectious Diseases (M.L., G.J., M.E.) and Biostatistics (S. Kim), Harvard School of Public Health, Boston; Institut National d'Etudes Démographiques, Paris (S.L.C.); the Family Health Research Center, Mahidol University, Bangkok, Thailand (S. Koetsawang); the New England Newborn Screening Program, University of Massachusetts Medical School, Boston (A.M.C.); the Ministry of Public Health, Bangkok, Thailand (W.P.); Children's Hospital and the Department of Pediatrics, Harvard Medical School, Boston (K.M.); and the Department of Microbiology, Chiang Mai University Medical School, Chiang Mai, Thailand (V.V.).

Address reprint requests to Dr. Lallemant at PHPT, 57/2 Faham Rd., Soi 3, Muang Chiang Mai 50000, Thailand, or at lecoeur{at}loxinfo.co.th or lalleman{at}ird.fr.

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