Inflammation Clinical Trial
Official title:
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.
Our general goal is to evaluate the potential effectiveness of losartan (100mg daily) for
reducing inflammation and improving immune recovery, given the potential for these treatment
effects to reduce risk for long-term non-AIDS-defining complications among older HIV positive
participants. Prior to conducting a clinical outcome trial, candidate treatments must be
studied among HIV positive patients given the unique pathogenesis driving inflammation and
disease risk.
The potential benefits of losartan (100mg daily) will be studied among HIV positive
individuals over age 50 years whose CD4 counts remain ≤600 cells/mm3. Participants (n=110, 55
per group) will be randomized to receive losartan or matching placebo daily. After
randomization, participants will start losartan (or placebo) at a dose of 50mg once daily,
increasing to 100mg once daily at the 2-week study visit pending results of a week 2 toxicity
lab evaluation (see 2.4 below for criteria). Following month 1, participants will return for
follow-up study visit procedures at months 3, 6, 9, and 12.
Changes from baseline in measures of inflammation, immune activation, immune recovery and
fibrosis within lymphatic tissues will be studied. The primary outcome will be the average of
IL-6 levels over 12 months, and the main secondary outcome will be change in CD4 count in
blood over 12 months.
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