Forty asymptomatic I-W-infected individuals with CD4+ lymphocyte levels abo
ve 400 x 10(6)/l were immunized over 5 years with recombinant envelope glyc
oprotein gp160 (rgp160). After 5 years there was a trend towards more nonpr
ogressors in the immunized group as compared to the matched controls. Since
immunizations could activate HIV, the first 6 immunizations were followed
by 2 weeks of zidovudine or placebo, double-blind. The viral load did not c
hange during the first 6 months and was not different from that of the matc
hed controls after 5 years. The best effect on CD4+ lymphocyte development
was seen in individuals with a high viral load randomized to rgp160 + zidov
udine and in individuals with a low viral load randomized to rgp160 + place
bo. We conclude that rgp160 is safe and results in temporarily improved CD4
+ development. Concomitant antiviral treatment might be of benefit, especia
lly in patients with a more advanced disease and can today be given with mo
re effective combinations.