A Placebo-Controlled Trial of Ranitidine in Patients with Early Human Immunodeficiency Virus Infection

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 i...

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Bibliographic Details
Published in:The Journal of infectious diseases 1998-01, Vol.177 (1), p.231-234
Main Authors: Bartlett, John A., Berry, Paul S., Bockman, K. Wayne, Stein, Allan, Johnson, Judy, Graham, Shannon, Quinn, Joseph, DeMasi, Ralph, Alexander, W. James
Format: Article
Language:English
Subjects:
Adult
AIDS/HIV
beta 2-Microglobulin - analysis
Biological and medical sciences
CD4 Lymphocyte Count
CD56 Antigen - analysis
CD8 Antigens - analysis
Concise Communications
Double-Blind Method
Experimentation
Female
Histamine H2 Antagonists - administration & dosage
Histamine H2 Antagonists - therapeutic use
HIV
HIV - isolation & purification
HIV Core Protein p24 - analysis
HIV infections
HIV Infections - blood
HIV Infections - drug therapy
Humans
Immunology
Immunomodulators
Infections
Lymphocytes
Male
Medical sciences
Natural killer cells
Pharmacology. Drug treatments
Placebos
Plasma - virology
Ranitidine - administration & dosage
Ranitidine - therapeutic use
RNA
RNA, Viral - analysis
RNA, Viral - isolation & purification
Virology
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Summary: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 frombaseline between the 2 treatment groups in absolute CD4 cell number, plasma HIV RNA level, or most other surrogate markers of HIV infection. Serum β2-microglobulin levels were significantly lower in placebo than ranitidine recipients. Ranitidine should not be recommended for the treatment of HIVinfected patients unless it is used for established indications.
ISSN:0022-1899
1537-6613
DOI:10.1086/517361