NCT02513771

Sitagliptin for Reducing Inflammation and Immune Activation

A Randomized, Double-Blinded, Placebo-Controlled Trial of a Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin, Januvia) for Reducing Inflammation and Immune Activation in HIV-Infected Men and Women: A Multicenter Trial of the AIDS Clinical Trials Group (ACTG)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate whether sitagliptin (Januvia is the brand name for sitagliptin) reduces inflammation and immune activation markers in HIV-infected men and women when compared to a placebo (inactive medication like a dummy pill). The study evaluated whether taking 100 mg of sitagliptin by mouth daily for 16 weeks is safe and effective for HIV-infected persons on antiretroviral therapy (ART) who do not have diabetes. Sitagliptin is a medication that is used to treat people with diabetes (high blood sugar) but also may reduce inflammation in the body.

Detailed description

ACTG A5346 is a phase II, randomized, double-blinded, placebo-controlled, trial of sitagliptin 100 mg vs. placebo for 16 weeks followed by a 4-week post-intervention follow-up. A5346 studied whether sitagliptin reduced plasma concentrations of sCD14 in HIV-infected men and women ≥18 years of age who were on suppressive ART with HIV-1 RNA below the limit of quantification at screening and for at least the prior 48 weeks. Participants were randomized 1:1 to Sitagliptin arm vs. Placebo arm, and were stratified by screening CD4 count (100-350 vs. \>350 cells/mm\^3) and statin use (on statins vs. not on statins).

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Sitagliptin	100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up
DRUG	Placebo for sitagliptin	One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-13
• Completion: 2017-01-10
• First posted: 2015-08-03
• Last updated: 2018-06-18
• Results posted: 2018-01-05

Locations

16 sites across 1 country: United States