HIV Infections Clinical Trial
Official title:
Short ZDV Course to Prevent Perinatal HIV in Thailand
The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child transmission of HIV: and to assess and compare the safety and tolerance of the long and shortened ZDV regimens.
Multicenter, randomized, four arms, double-blind, controlled study. Consenting pregnant
women were tested for HIV from the beginning of pregnancy until 26 of gestational age (GA).
If HIV-positive and eligible, women completed a Pre-entry baseline check-up. Enrollment took
place at 28 weeks' gestational age. Women meeting selection criteria were randomly assigned
to one of four study arms (see below).
AMENDMENT (March 20, 1999)
Data Safety and Monitory Board interim review (March 17, 1999) The DSMB reported that the
transmission rate in the longest arm (long treatment of both mother and baby), was
significantly lower than that in the shortest arm (short treatment of both the mother and
the baby) and this discrepancy was larger than the previously agreed on difference which, if
found, would call for changing the study design. In addition, the transmission rates in the
remaining two arms of the study were similar to that in the longest arm. The difference that
was found could not be explained by any baseline characteristics of the participants, such
as maternal age, gestational age at delivery, birth weight, cesarean section rate, or any
others.
The DSMB recommended that enrollment into the shortest arm of the study be terminated, and
the study be continued with a modification of design so that new enrollees would enter one
of the three remaining arms.
All women enrolled before this amendment was effective and delivering after March 20th,
1999, and previously randomized to the Smother-Sinfant arm, were unblinded in order to give
their infants open label zidovudine for 6 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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