Mesalamine to Reduce T Cell Activation in HIV Infection

Phase 4 Completed 33 enrolled University of California, San Francisco Bausch Health Americas, Inc. · collab California HIV/AIDS Research Program · collab

RandomizedCrossoverDouble-blindTreatment

Summary

The objective of this study is to determine whether 12 weeks of mesalamine therapy added to a standard HIV treatment decreases systemic immune activation and inflammation in HIV-infected patients, possibly resulting in better recovery of the immune system. The study hypothesis is that decreasing inflammation directly in the gut may decrease both of these potential causes of chronic inflammation, potentially resulting in an immunologic benefit.

Timeline

Start: 2010-06
Primary completion: 2012-12
Completion: 2012-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Mesalamine Then Placebo vs Placebo Then Mesalamine; p = 0.63; t-test, 2 sided; note: Significant at p\<0.05 NCT01090102 ↗

paper mesalamine-treated subjects did not experience any significant change in the percent CD38+HLA-DR+ peripheral blood CD4+ and CD8+ T cells PMID 25545673 ↗

Publications

Somsouk M, Dunham RM, Cohen M, Albright R, Abdel-Mohsen M, Liegler T, Lifson J, Piatak M, Gorelick R, Huang Y, Wu Y, Hsue PY, Martin JN, Deeks SG, McCune JM, Hunt PW. The immunologic effects of mesalamine in treated HIV-infected individuals with incomplete CD4+ T cell recovery: a randomized crossover trial. PLoS One. 2014 Dec 29;9(12):e116306. doi: 10.1371/journal.pone.0116306. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	1.5 g	Oral