CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Mesalamine (5-aminosalicylic acid, Apriso) +1 moredrug
Likely dose
Mesalamine (5-aminosalicylic acid, Apriso) 1.5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01090102
NCT01090102Phase 4Completed

Mesalamine to Reduce T Cell Activation in HIV Infection

University of California, San Francisco·interventional·Posted Mar 19, 2010·Updated Aug 13, 2014

In Brief

A Phase 4 clinical trial evaluating Mesalamine (5-aminosalicylic acid, Apriso) and Placebo for HIV Infections and 4 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.3 years ago

Interventions

Mesalamine (5-aminosalicylic acid, Apriso)drug

Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth). Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).

Placebodrug

Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth). Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).