ZIDOVUDINE TREATMENT IN PATIENTS WITH PRIMARY (ACUTE) HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 INFECTION - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

A multicenter, double-blind, placebo-controlled trial randomized 28 pa tients with primary (acute) human immunodeficiency virus (HIV)-1 infec tion (PHI) to receive zidovudine, 1000 mg daily, or placebo for 24 wee ks. At week 48, compared with placebo patients, zidovudine-treated pat ients had significantly higher CD4 cell counts (zidovudine, 666 cells/ mm(3); placebo, 362; P =.004) and lower peripheral blood mononuclear c ell (PBMC) culture titers (zidovudine, 0.58 log infectious units per m illion cells; placebo, 1.68; P =.02) but no difference in plasma RNA ( zidovudine, 3.93 log copies/mL; placebo, 4.00; P =.83). Serious advers e events and minor clinical events were infrequent and comparable in b oth arms. There were two deaths: 1 patient died of sepsis and renal di sease (zidovudine arm), and 1 patient died of sepsis and tension pneum othorax (placebo arm). Six months of high-dose zidovudine initiated du ring PHI results in higher CD4 cell counts and lower PBMC culture tite rs but no difference in plasma HIV-1 RNA. Further studies with more po tent antiretroviral combination therapies ape warranted.