title: A placebo-controlled trial of ranitidine in patients with early human immunodeficiency virus infection.
abstract: 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.
authors.affiliation: Duke University Medical Center, Durham, North Carolina 27710, USA. jab5@acpub.duke.edu
authors.forename: J A
authors.initials: JA
authors.lastname: Bartlett
authors.forename: P S
authors.initials: PS
authors.lastname: Berry
authors.forename: K W
authors.initials: KW
authors.lastname: Bockman
authors.forename: A
authors.initials: A
authors.lastname: Stein
authors.forename: J
authors.initials: J
authors.lastname: Johnson
authors.forename: S
authors.initials: S
authors.lastname: Graham
authors.forename: J
authors.initials: J
authors.lastname: Quinn
authors.forename: R
authors.initials: R
authors.lastname: DeMasi
authors.forename: W J
authors.initials: WJ
authors.lastname: Alexander
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D019002:CD56 Antigen / Q000032:analysis; D016827:CD8 Antigens / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D006678:HIV / Q000302:isolation & purification; D016655:HIV Core Protein p24 / Q000032:analysis; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010949:Plasma / Q000821:virology; D012367:RNA, Viral / Q000032:analysis / Q000302:isolation & purification; D011899:Ranitidine / Q000008:administration & dosage / Q000627:therapeutic use*; D001613:beta 2-Microglobulin / Q000032:analysis
chemical_list: D019002:CD56 Antigen; D016827:CD8 Antigens; D016655:HIV Core Protein p24; D006635:Histamine H2 Antagonists; D012367:RNA, Viral; D001613:beta 2-Microglobulin; D011899:Ranitidine