WESTPORT, CT (Reuters Health) - At 18 months, short-course zidovudine
therapy administered during late pregnancy has no significant adverse
effects on infants born to HIV-infected mothers, according to the
results of a recent trial conducted in Bangkok.

In an online report published in the January issue of Pediatrics, Dr.
R. J. Simonds, from the Centers for Disease Control and Prevention,
and colleagues with the Bangkok Collaborative Perinatal HIV
Transmission Study Group, describe the outcome of children born to
HIV-infected mothers between June 1996 and February 1998.

The researchers randomized 393 HIV-infected pregnant women to receive
zidovudine or a placebo regimen starting at 36 weeks' gestation. The
treatment group received 300 mg of zidovudine twice daily until labor
began and then they received 300 mg every 3 hours until delivery.

Of the 395 children who were born, 55 were HIV-infected, 330 were
uninfected, and in 10 the infection status could not be determined.
Eighteen-month follow-up was completed for 319 children. Fourteen
children died before 18 months of age, the authors state.

Although at birth the mean hematocrit among uninfected children in the
zidovudine group was lower than in the control group, this was not the
case at later ages. Mean weight, height, head circumference, CD4+ and
CD8+ T-cell counts were similar between both groups at all ages.

More febrile convulsions were noted among uninfected children in the
zidovudine group than in the control group, but the difference was not
significant. "No other signs suggestive of mitochondrial dysfunction
and no tumors were observed" in uninfected children, the researchers
note.

During the 18-month follow-up, the majority of infected children in
both groups survived free of CDC class C disease, the investigators
point out.

"Our trial previously demonstrated that a short course of antenatal
zidovudine can significantly reduce the risk for mother-infant HIV
transmission," Dr. Simond's team explains. "Eighteen months of
follow-up of these children now shows no major adverse events
associated with short-course zidovudine."

"Whether adverse events will appear with more widespread use of this
regimen or after many years of follow-up remains unknown, and
monitoring for late-appearing adverse events will be challenging," the
authors emphasize.

1/10/01