Title: 6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Cote d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial.

POPLINE Document Number: 141400

Author(s):

Dabis F
Msellati P
Meda N
Welffens-Ekra C
You B
Manigart O
Leroy V
Simonon A
Cartoux M
Combe P

Source citation:

Lancet, 1999 Mar 6;353(9155):786-92.

Abstract:

The provision of zidovudine drug therapy to pregnant women has been shown to reduce the vertical transmission of HIV in non-breast-feeding study populations. However, many women in developing countries have little to no option but to breast-feed their infants. Findings are presented from an assessment of the acceptability, tolerance, and 6-month efficacy of a short regimen of oral zidovudine in African populations practicing breast-feeding. The randomized, double-blind placebo-controlled trial was conducted in public clinics of Abidjan, Cote d'Ivoire, and Bobo-Dioulasso, Burkina Faso. Eligible participants were women aged 18 years or older, with confirmed HIV-1 infection and pregnancy of 36-38 weeks duration, and who gave their written consent. Exclusion criteria were severe anemia, neutropenia, abnormal liver function, and sickle-cell disease. Subjects were randomly assigned to receive either zidovudine or placebo. The 214 women who received zidovudine did so in a 300 mg dose twice daily until labor, 600 mg at the beginning of labor, and 300 mg twice daily for 7 days postpartum. 217 women received placebo. The women were enrolled between September 1995 and February 1998. The Kaplan-Meier probability of HIV infection in the infant at age 6 months was 18.0% in the zidovudine group and 27.5% in the placebo group. Adjustment for potential confounders did not change the treatment effect. A short-course regimen of oral zidovudine given during the peripartum period is therefore well accepted and well tolerated, and provides a 38% reduction in the level of early vertical transmission of HIV-1 infection despite breast-feeding.

Keywords:

Burkina Faso
Cote d'Ivoire
Research Report
Pregnant Women
Breastfeeding
HIV Prevention
AIDS Prevention
Mother-to-Child Transmission
Drugs
Prevention and Control
Developing Countries
Africa, Western
Africa, Sub Saharan
Africa
Population Characteristics
Demographic Factors
Population
Infant Nutrition
Nutrition
Health
HIV Infections
Viral Diseases
Diseases
AIDS
Treatment