PHARMACOLOGICAL AND METHODOLOGICAL BASES FOR THE EVALUATION OF TREATMENTS AIMED AT PREVENTING MOTHER-TO-CHILD TRANSMISSION OF THE HUMAN-IMMUNODEFICIENCY-VIRUS
D. Feldman et al., PHARMACOLOGICAL AND METHODOLOGICAL BASES FOR THE EVALUATION OF TREATMENTS AIMED AT PREVENTING MOTHER-TO-CHILD TRANSMISSION OF THE HUMAN-IMMUNODEFICIENCY-VIRUS, Annales de pediatrie, 41(8), 1994, pp. 493-501
Vertical transmission is responsible for the overwhelming majority of
cases of human immunodeficiency virus (HIV) infection in children. Whe
ther vertical transmission of the HIV occurs predominantly in utero, d
uring delivery, or during breast feeding remains unsettled. Measures o
f potential usefulness for preventing vertical transmission of the HIV
include contraception or elective termination of pregnancy in HIV-pos
itive women, and delivery by cesarean section followed by bottle feedi
ng of infants born to HIV-positive mothers. Preclinical and clinical s
tudies of the prevention of vertical HIV transmission have been carrie
d out with anti-HIV immunoglobulins, CD4-IgG or immunoadhesine, interf
eron alpha, zidovudine, and didanosine. Drugs with the greatest preven
tive potential may be zidovudine (currently under evaluation in a Phas
e III, multicenter, randomized, double-blind, placebo-controlled ACTG
study [ACTG 076]) and immunoadhesine CD4-IgG (which has yielded promis
ing results in animal models). There is a need for additional biologic
al and epidemiological data on vertical HIV transmission. Clinical tri
als focusing on efficacy and safety are at a very early stage and will
have to solve a number of methodological and ethical problems. They s
hould be conducted using methods similar to those of the ACTG 076 tria
l. Evaluation of the risk/benefit ratio and cost-effectiveness of thes
e treatments will need to be performed with the goal of reducing the i
ncidence of HIV infection in children.