CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Sitagliptin +1 moredrug
Likely dose
Sitagliptin 100 mgfrom 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/NCT02513771
NCT02513771Phase 2Completed

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)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Aug 3, 2015·Updated Jun 18, 2018

In Brief

A Phase 2 clinical trial evaluating Sitagliptin and Placebo for sitagliptin for HIV-1 Infection. Completed, enrolled 90 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 3, 2015
Enrollment StartSep 1, 2015
Primary CompletionDec 13, 2016
Study CompletionJan 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago

Interventions

Sitagliptindrug

100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up

Placebo for sitagliptindrug

One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.