title: The immunologic effects of mesalamine in treated HIV-infected individuals with incomplete CD4+ T cell recovery: a randomized crossover trial.
abstract: The anti-inflammatory agent, mesalamine (5-aminosalicylic acid) has been shown to decrease mucosal inflammation in ulcerative colitis. The effect of mesalamine in HIV-infected individuals, who exhibit abnormal mucosal immune activation and microbial translocation (MT), has not been established in a placebo-controlled trial. We randomized 33 HIV-infected subjects with CD4 counts <350 cells/mm3 and plasma HIV RNA levels <40 copies/ml on antiretroviral therapy (ART) to add mesalamine vs. placebo to their existing regimen for 12 weeks followed by a 12 week crossover to the other arm. Compared to placebo-treated subjects, mesalamine-treated subjects did not experience any significant change in the percent CD38+HLA-DR+ peripheral blood CD4+ and CD8+ T cells at week 12 (P = 0.38 and P = 0.63, respectively), or in the CD4+ T cell count at week 12 (P = 0.83). The percent CD38+HLA-DR+ CD4+ and CD8+ T cells also did not change significantly in rectal tissue (P = 0.86, P = 0.84, respectively). During the period of mesalamine administration, plasma sCD14, IL-6, D-dimer, and kynurenine to tryptophan ratio were not changed significantly at week 12 and were similarly unchanged at week 24. This study suggests that, at least under the conditions studied, the persistent immune activation associated with HIV infection is not impacted by the anti-inflammatory effects of mesalamine.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01090102.
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of California San Francisco, San Francisco, CA, 94110, United States of America.
authors.forename: Ma
authors.initials: M
authors.lastname: Somsouk
authors.affiliation: Division of Experimental Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Dunham
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Michelle
authors.initials: M
authors.lastname: Cohen
authors.affiliation: Division of Experimental Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Albright
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Mohsen
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Teri
authors.initials: T
authors.lastname: Liegler
authors.affiliation: AIDS and Cancer Virus Program, Leidos Biomedical Research Inc., Frederick National Laboratory, Frederick, MD, United States of America.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lifson
authors.affiliation: AIDS and Cancer Virus Program, Leidos Biomedical Research Inc., Frederick National Laboratory, Frederick, MD, United States of America.
authors.forename: Michael
authors.initials: M
authors.lastname: Piatak
authors.affiliation: AIDS and Cancer Virus Program, Leidos Biomedical Research Inc., Frederick National Laboratory, Frederick, MD, United States of America.
authors.forename: Robert
authors.initials: R
authors.lastname: Gorelick
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of California San Francisco, San Francisco, CA, 94110, United States of America.
authors.forename: Yong
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of California San Francisco, San Francisco, CA, 94110, United States of America.
authors.forename: Yuaner
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Division of Cardiology, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Priscilla Y
authors.initials: PY
authors.lastname: Hsue
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Martin
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Deeks
authors.affiliation: Division of Experimental Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: McCune
authors.affiliation: Positive Health Program, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Hunt
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D001916:Brachial Artery / Q000187:drug effects / Q000503:physiopathology; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology*; D002318:Cardiovascular Diseases / Q000276:immunology / Q000503:physiopathology / Q000821:virology; D018592:Cross-Over Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology*; D006801:Humans; D007249:Inflammation / Q000473:pathology; D008213:Lymphocyte Activation / Q000276:immunology; D008297:Male; D019804:Mesalamine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D012007:Rectum / Q000473:pathology; D012995:Solubility; D014664:Vasodilation / Q000187:drug effects
chemical_list: D015415:Biomarkers; D019804:Mesalamine