TreatmentUpdate57, Vol. 7, No. 3 - March 1995
Sean Hosein

We now report results from the study ANRS 024/ ACTG 076. Researchers randomly assigned subjects to one of 2 arms in the study; either AZT or placebo. Those assigned to AZT received 500 mg/day orally before giving birth and during birth they received iv AZT 2mg/kg of body weight for 1 hour, "followed by 1 mg/kg/hour until birth." After birth the infant received AZT 2 mg/kg every 6 hours for 6 weeks. Subjects and their infants received regular monitoring. For their analysis, researchers used data from 205 women assigned to receive AZT and 204 women assigned to placebo. Neither doctors nor subjects were supposed to know who received AZT and who did not. At least 1/2 of the subjects:

- were 25 years old - had 550 CD4+ cells - were pregnant for 6 months before entering the study - received AZT for 11 weeks before giving birth

* EFFECT(S) OF AZT

Researchers made decisions about the effect of AZT or placebo in a number of ways. In one calculation, 180 mothers and their infants received AZT while 183 others did not. Roughly 8% of infants born to mothers in the AZT arm were infected as were 26% of those born to mothers in the placebo arm. Since 8% of infants born to mothers who used AZT were also HIV-infected, treatment with AZT does not provide 100% protection.

* TOXICITY--THE MOTHERS

Roughly the same proportion of women reported side effects in each arm of the study. There were no deaths among the mothers in either arm during the study. Six months after birth, 95% of women in both arms of the study had CD4+ cell counts "greater than 300 CD4+ cells".

* TOXICITY--THE INFANTS

Five deaths occurred in subjects receiving AZT and 3 others in those assigned to placebo. None of these deaths appeared to be caused by AZT or placebo. Doctors detected a variety of physical defects in 33 infants but these were evenly divided between the 2 arms of the trial. Nearly twice as many infants given AZT had reduced blood levels of haemoglobin (needed for moving oxygen) than others not given the drug. Six weeks after birth (when they stopped using AZT) haemoglobin rose. References appear in section F below.

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