Objective: The potential role of antiretroviral treatment on the infec
tiousness of HIV-1-infected men was examined by studying the effect of
antiviral treatment on the shedding of HIV-1 in semen. Methods: Forty
-four patients enrolled in various treatment protocols were asked to d
onate a semen sample before they began a new antiviral treatment and a
l a follow-up visit after 6 to 15 weeks of treatment. Since most patie
nts were on blinded protocols, patients were stratified by response of
blood viral load. The effect of each patient's treatment was classifi
ed as good (n = 24), fair (n = 8) and marginal (n = 13) by measurement
of the HIV RNA reduction in blood plasma (> 1.0 log(10); 0.5-1.0 log(
10), and <0.5 log(10) HIV RNA copies/ml reduction, respectively). The
effect of treatment on shedding of HIV-1 in semen was documented by th
e reduction of HIV RNA concentration in seminal plasma and by quantita
tive HIV-1 seminal cell culture. Results: Overall, antiviral treatment
resulted in a significant fall in the viral load in semen (RNA and cu
lture) that paralleled the reduction of viral load in blood. More pron
ounced reductions of HIV RNA in semen were observed as the effectivene
ss of treatment on blood HIV RNA levels increased (median drop from ba
seline 0, 0.3 log(10) and 0.8 log(10) RNA copies/ml in patients with m
arginal, fair and good treatment effect, respectively). Thirteen patie
nts lost detectable HIV RNA in blood on treatment and all of these had
undetectable levels of HIV-1 in semen by culture and RNA analysis at
follow-up. In 19 of the 31 patients (62%) who still had HIV RNA in the
ir blood during treatment, semen HIV levels were below detection in se
men at follow-up. Conclusions: Treatment-induced changes of HIV RNA co
ncentration in blood are generally associated with a corresponding cha
nge in seminal HIV RNA: If confirmed in larger studies, potent antiret
roviral therapy might reduce the spread of HIV-1.