A PLACEBO-CONTROLLED TRIAL OF RANITIDINE IN PATIENTS WITH EARLY HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

Previous uncontrolled reports have suggested that H-2-antagonists may possess immunomodulatory activity in human immunodeficiency virus (HIV )-infected patients, Such trials reported improvements in HIV-related symptoms, increased absolute CD4 cell numbers, and improvements in oth er measures of host immunity, The present trial was a randomized, plac ebo-controlled, double-blind trial of ranitidine 300 mg (orally twice daily) in subjects with early HIV infection (absolute CD4 cells, 400-7 00/mm(3)), Eighty-one subjects entered the trial and 73 completed 16 w eeks on study medications, There were no significant differences in th e time-weighted average change from baseline between the 2 treatment g roups in absolute CD4 cell number, plasma HIV RNA level, or most other surrogate markers of HIV infection, Serum beta(2)-microglobulin level s were significantly lower in placebo than ranitidine recipients, Rani tidine should not be recommended for the treatment of HIV-infected pat ients unless it is used for established indications.