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

Antiretroviral therapy may lead to decreased shedding of human immunodefici ency virus type 1 (HIV-1) in genital secretions. Thirty men, 19 receiving a mprenavir and ii receiving amprenavir, zidovudine, and lamivudine, donated blood and semen while undergoing treatment, to evaluate the effects of thes e medications on HIV-1 shedding in semen. Before therapy, 4 men had HIV-1 R NA levels in seminal plasma >6.0 log(10) (1 million) copies/mL, markedly hi gher than levels in blood plasma. Most men (77%) had HIV-1 RNA levels in se minal plasma below the limit of quantification during therapy. Amprenavir a lone suppressed I HIV-1 RNA levels to <400 copies/mL in seminal plasma in t he majority of patients, the first direct demonstration of the antiretrovir al effects of a protease inhibitor in the male genital tract. However, 8 me n (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 tran smission of HIV-1.