BACKGROUND: This is the first report on the preliminary efficacy of 4 different short-course nucleoside analogue regimens (stavudine [d4T], didanosine [ddI], d4T+ddI, and zidovudine [ZDV]) for the prevention of mother-to-child transmission of HIV-1 (MTCT) in a resource-limited setting. DESIGN: This prospective open-label, randomized 4-arm study (May 1999 to May 2000) conducted in South Africa enrolled 373 women from 34 weeks of gestation; medication was continued through delivery and for 6 weeks to infants. MTCT rates were ascertained at birth, 6, 12, and 24 weeks of age. RESULTS:Mean maternal HIV-1 RNA levels decreased rapidly on treatment in all groups. At week 4, the mean decrease was 1.91 log10 copies/mL (c/mL) in the d4T+ddI group, 1.33 log10 c/mL in the ddI group, 1.12 log10 c/mL in the d4T group, and 0.76 log10 c/mL in the ZDV group. Among the 362 evaluable mother-infant pairs, 11 infants in the d4T group, 10 in the ddI group, 5 in the ZDV group, and 4 in the d4T+ddI group were infected by 24 weeks of age. Eleven infections occurred in utero. Treatment with d4T and ddI was not associated with lactic acidosis or hepatic steatosis. CONCLUSIONS: The abbreviated use of nucleoside analogues for the prevention of MTCT appears safe and effective.
RCT Entities:
BACKGROUND: This is the first report on the preliminary efficacy of 4 different short-course nucleoside analogue regimens (stavudine [d4T], didanosine [ddI], d4T+ddI, and zidovudine [ZDV]) for the prevention of mother-to-child transmission of HIV-1 (MTCT) in a resource-limited setting. DESIGN: This prospective open-label, randomized 4-arm study (May 1999 to May 2000) conducted in South Africa enrolled 373 women from 34 weeks of gestation; medication was continued through delivery and for 6 weeks to infants. MTCT rates were ascertained at birth, 6, 12, and 24 weeks of age. RESULTS: Mean maternal HIV-1 RNA levels decreased rapidly on treatment in all groups. At week 4, the mean decrease was 1.91 log10 copies/mL (c/mL) in the d4T+ddI group, 1.33 log10 c/mL in the ddI group, 1.12 log10 c/mL in the d4T group, and 0.76 log10 c/mL in the ZDV group. Among the 362 evaluable mother-infant pairs, 11 infants in the d4T group, 10 in the ddI group, 5 in the ZDV group, and 4 in the d4T+ddI group were infected by 24 weeks of age. Eleven infections occurred in utero. Treatment with d4T and ddI was not associated with lactic acidosis or hepatic steatosis. CONCLUSIONS: The abbreviated use of nucleoside analogues for the prevention of MTCT appears safe and effective.