A placebo-controlled trial of ranitidine in patients with early human immunodeficiency virus infection

J Infect Dis. 1998 Jan;177(1):231-4. doi: 10.1086/517361.


Previous uncontrolled reports have suggested that H2-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 other measures of host immunity. The present trial was a randomized, placebo-controlled, double-blind trial of ranitidine 300 mg (orally twice daily) in subjects with early HIV infection (absolute CD4 cells, 400-700/mm3). Eighty-one subjects entered the trial and 73 completed 16 weeks on study medications. There were no significant differences in the time-weighted average change from baseline between the 2 treatment groups in absolute CD4 cell number, plasma HIV RNA level, or most other surrogate markers of HIV infection. Serum beta2-microglobulin levels were significantly lower in placebo than ranitidine recipients. Ranitidine should not be recommended for the treatment of HIV-infected patients unless it is used for established indications.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • CD4 Lymphocyte Count
  • CD56 Antigen / analysis
  • CD8 Antigens / analysis
  • Double-Blind Method
  • Female
  • HIV / isolation & purification
  • HIV Core Protein p24 / analysis
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • Histamine H2 Antagonists / administration & dosage
  • Histamine H2 Antagonists / therapeutic use*
  • Humans
  • Male
  • Plasma / virology
  • RNA, Viral / analysis
  • RNA, Viral / isolation & purification
  • Ranitidine / administration & dosage
  • Ranitidine / therapeutic use*
  • beta 2-Microglobulin / analysis


  • CD56 Antigen
  • CD8 Antigens
  • HIV Core Protein p24
  • Histamine H2 Antagonists
  • RNA, Viral
  • beta 2-Microglobulin
  • Ranitidine