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NCT02513771 · ClinicalTrials.gov registry record · Phase 2

Sitagliptin for Reducing Inflammation and Immune Activation

A Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

Completed
Registry status
Phase 2
Development phase
90
Enrollment target

NCT02513771: Completed Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

NCT02513771 is a Phase 2 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02513771, a Phase 2 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

COMPLETED
Registry status
Phase 2
Development phase
90 participants
Enrollment target

Study 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.

Primary Outcome

sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation. The outcome measures are changes in log10 transformed sCD14 from baseline to week 15/16 (week 15/16 - baseline) Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 15 and week 16 were averaged for week 15/16.

Interventions

  • DRUG Sitagliptin
  • DRUG Placebo for sitagliptin

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2015-09
Est. Completion 2017-01-10
Phase Phase 2

What the finished NCT02513771 record still lists

NCT02513771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Sitagliptin is the first listed.

NCT02513771 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02513771 about?

NCT02513771 is a clinical study titled "Sitagliptin for Reducing Inflammation and Immune Activation". 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 si...

What is the current status of trial NCT02513771?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2015-09. Estimated completion is 2017-01-10.

What interventions are being tested in trial NCT02513771?

The interventions under investigation include: Sitagliptin (DRUG), Placebo for sitagliptin (DRUG).

Who is sponsoring clinical trial NCT02513771?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02513771's enrollment target sits among peer trials

90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02513771, the US trial registry maintained by the National Library of Medicine. NCT02513771 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.