The effects of zidovudine in the subset of infants infected with human immunodeficiency virus type-1 (Pediatric AIDS Clinical Trials Group Protocol 076).
OBJECTIVE
To describe the effect of zidovudine on human immunodeficiency virus type 1 (HIV-1) and on the course of disease in infants who became infected while they and their mothers received zidovudine preventive therapy or placebo in Pediatric AIDS Clinical Trials Group Protocol 076.


METHODS
Observational substudy of a multicenter, randomized, double-blind, placebo-controlled trial.


METHODS
We compared the progression of disease, timing of HIV-1 transmission, and the plasma HIV-1 RNA level in infected infants of mother-infant pairs who were randomly assigned to receive zidovudine (n = 14) or placebo (n = 43). The development of genotypic zidovudine resistance was assessed among infected infants in the zidovudine treatment group.


RESULTS
In this limited study, zidovudine therapy during pregnancy and labor and in the neonatal period for 6 weeks failed to have a major effect on rapid progression of disease, timing of transmission, and viral replication in HIV-infected infants. When the zidovudine treatment regimen failed to prevent maternal-infant transmission of HIV-1, resistance to zidovudine did not develop during study treatment.


CONCLUSIONS
Our study supports the safety of zidovudine use in pregnancy and in the newborn period but demonstrates the continued need for more potent antiretroviral treatment of the infected infant.
McSherry
G D
GD
Department of Pediatrics, UMD-New Jersey Medical School, Newark, New Jersey, USA.
Shapiro
D E
DE
Coombs
R W
RW
McGrath
N
N
Frenkel
L M
LM
Britto
P
P
Culnane
M
M
Sperling
R S
RS
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000473:pathology / Q000517:prevention & control*; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D004351:Drug Resistance / Q000235:genetics; D005260:Female; D005838:Genotype; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D011247:Pregnancy; D012367:RNA, Viral / Q000097:blood; D015215:Zidovudine / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D012367:RNA, Viral; D015215:Zidovudine