The effects of protease inhibitor therapy on human immunodeficiency virus type 1 levels in semen (AIDS clinical trials group protocol 850)

J Infect Dis. 2000 May;181(5):1622-8. doi: 10.1086/315447. Epub 2000 Apr 26.


Antiretroviral therapy may lead to decreased shedding of human immunodeficiency virus type 1 (HIV-1) in genital secretions. Thirty men, 19 receiving amprenavir and 11 receiving amprenavir, zidovudine, and lamivudine, donated blood and semen while undergoing treatment, to evaluate the effects of these medications on HIV-1 shedding in semen. Before therapy, 4 men had HIV-1 RNA levels in seminal plasma >6.0 log10 (1 million) copies/mL, markedly higher than levels in blood plasma. Most men (77%) had HIV-1 RNA levels in seminal plasma below the limit of quantification during therapy. Amprenavir alone suppressed HIV-1 RNA levels to <400 copies/mL in seminal plasma in the majority of patients, the first direct demonstration of the antiretroviral effects of a protease inhibitor in the male genital tract. However, 8 men (27%) had measurable HIV-1 in seminal plasma at their last study visit, 4 with increasing levels. Persistent replication of HIV in the genital tract may have implications for the selection of resistant virus and sexual transmission of HIV-1.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Carbamates
  • Double-Blind Method
  • Drug Therapy, Combination
  • Furans
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1 / isolation & purification*
  • HIV-1 / physiology
  • Humans
  • Lamivudine / therapeutic use*
  • Male
  • Middle Aged
  • RNA, Viral / analysis
  • RNA, Viral / blood
  • Regression Analysis
  • Semen / virology*
  • Sulfonamides / therapeutic use*
  • Virus Shedding / drug effects
  • Zidovudine / therapeutic use*


  • Carbamates
  • Furans
  • HIV Protease Inhibitors
  • RNA, Viral
  • Sulfonamides
  • Lamivudine
  • Zidovudine
  • amprenavir