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A randomized control trial of an Ultra-Short zidovudine regimen in the prevention of perinatal HIV transmission in rural Zimbabwe

Thistle, P., Gottesman, M., Pilon, R., Glazier, R.H., Arbess, G., Phillips, E., Wald, R.L., Chitsike, I., Simor, A., Chipato, T. and Silverman, M. (2004) A randomized control trial of an Ultra-Short zidovudine regimen in the prevention of perinatal HIV transmission in rural Zimbabwe. The Central African Journal of Medicine, 50 (9-10). pp. 79-84.

Abstract

OBJECTIVE
To assess the practicality and effectiveness of an Ultra-Short zidovudine regimen for prevention of perinatal HIV transmission in rural Zimbabwe.

DESIGN
Double-blinded placebo-controlled randomized clinical trial.

SETTING
The Salvation Army Howard Hospital, a district hospital in rural Zimbabwe.

SUBJECTS
222 HIV positive pregnant women presenting for antenatal care prior to 36 weeks were randomized. Twenty nine women were lost to follow up.

INTERVENTION
In the Thai regimen, mothers received zidovudine (300 mg po bid) from 36 weeks gestation until labour, and zidovudine (300 mg po q3h) during labour, and the neonates received a placebo. In the Ultra-Short regimen, the mothers received a placebo from 36 weeks to labour, then zidovudine (300 mg po q3h) in labour. The neonates received zidovudine (2 mg/kg po qid) for the first three days of life.

MAIN OUTCOME MEASURE
Infant HIV RNA status at six weeks of life.

RESULTS
Results were available for 90 infants from the Thai group and 89 infants from the Ultra-Short group. Infant HIV seroconversion rates at six weeks of life were 18.9% (95%CI 10.8 to 27.0) with the Thai regimen, and 15.7% [95% Confidence Interval (CI) 8.1 to 23.4] with the Ultra-Short regimen. The upper bound of seroconversion in the Ultra-Short group was lower than the 25% seroconversion boundary that was specified to show equivalence.

CONCLUSIONS
Although the Ultra-Short regimen has equivalent efficacy to the Thai regimen, it also has many practical advantages. Ultra-Short is thus a preferable protocol.

Publication Type: Journal Article
Publisher: African Journals Online
Publishers Website: http://www.ajol.info/index.php/cajm/index
URI: http://researchrepository.murdoch.edu.au/id/eprint/16080
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