Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus type 1 infection

N Engl J Med. 1997 May 8;336(19):1343-9. doi: 10.1056/NEJM199705083361902.


Background: In infants and children with maternally acquired human immunodeficiency virus type 1 (HIV-1) infection, treatment with a single antiretroviral agent has limited efficacy. We evaluated the safety and efficacy of a three-drug regimen in a small group of maternally infected infants.

Methods: Zidovudine, didanosine, and nevirapine were administered in combination orally to eight infants 2 to 16 months of age. The efficacy of antiretroviral treatment was evaluated by serial measurements of plasma HIV-1 RNA, quantitative plasma cultures, and quantitative cultures of peripheral-blood mononuclear cells.

Results: The three-drug regimen was well tolerated, without clinically important adverse events. Within four weeks, there were reductions in plasma levels of HIV-1 RNA of at least 96 percent (1.5 log) in seven of the eight study patients. Over the 6-month study period, replication of HIV-1 was controlled in two infants who began therapy at 2 1/2 months of age. Plasma RNA levels were reduced by 0.5 to 1.5 log in five of the other six infants.

Conclusions: Although further observations are needed, it appears that in infants with maternally acquired HIV-1 infection, combined treatment with zidovudine, didanosine, and nevirapine is well tolerated and has sustained efficacy against HIV-1.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Oral
  • Anti-HIV Agents / blood
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count / drug effects
  • Didanosine / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV-1* / drug effects
  • HIV-1* / isolation & purification
  • Humans
  • Infant
  • Infectious Disease Transmission, Vertical
  • Male
  • Nevirapine
  • Pyridines / blood
  • Pyridines / therapeutic use*
  • RNA, Viral / blood
  • Viral Load
  • Zidovudine / therapeutic use*


  • Anti-HIV Agents
  • Pyridines
  • RNA, Viral
  • Zidovudine
  • Nevirapine
  • Didanosine