NCT02513771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2016

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 5, 2018

Completed
Last Updated

June 18, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

July 13, 2015

Results QC Date

November 6, 2017

Last Update Submit

May 18, 2018

Conditions

HIV-1 Infection

Keywords

SitagliptinInflammationImmune activationViral suppressionHIV-1Immunology biomarkerssCD14

Outcome Measures

Primary Outcomes (1)

  • Change in sCD14 From Baseline to Week 15/16

    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.

    Pre-entry, Week 0, Week 15, Week 16

Secondary Outcomes (15)

  • Change in sCD14 From Week 15/16 to Week 20

    Week 15, week 16, week 20

  • Change in sCD163

    Week 0, week 15, week 20

  • Change in sCD26

    Week 0, week 15, week 20

  • Change in IL-6

    Week 0, week 15, week 20

  • Change in hsCRP

    Week 0, week 15, week 20

  • +10 more secondary outcomes

Study Arms (2)

Sitagliptin Arm

ACTIVE COMPARATOR

Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.

Drug: Sitagliptin

Placebo Arm

PLACEBO COMPARATOR

Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.

Drug: Placebo for sitagliptin

Interventions

SitagliptinDRUG

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

Also known as: Januvia
Sitagliptin Arm
Placebo for sitagliptinDRUG

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

Also known as: Placebo
Placebo Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented HIV-1 infection.
  • Currently on an antiretroviral regimen consisting of at least 2 NRTIs and either a protease inhibitor boosted with low dose ritonavir, an integrase inhibitor, or an NNRTI. (Other ART regimens may be acceptable. Sites must consult the protocol team for approval)
  • Currently on continuous ART for ≥48 weeks prior to study entry with no interruption longer than 7 consecutive days during that period.
  • Plasma HIV-1 RNA levels below 75 copies/mL for at least 48 weeks prior to study entry. The participant must have a minimum of two values in the last 48 weeks obtained \>30 days apart, with the most recent value obtained within 90 days prior to entry. (Single determinations that are between the assay quantification limit and 500 copies/mL (i.e., "blips") are allowed as long as the preceding and subsequent determinations are below the level of quantification).
  • CD4+ cell count ≥100 cells/mm\^3 obtained within 90 days prior to study entry.
  • The following laboratory values obtained within 90 days prior to entry.
  • Absolute neutrophil count (ANC) ≥750/mm\^3
  • Hemoglobin ≥8.0 g/dL
  • Platelet count ≥50,000/mm\^3
  • Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockroft-Gault formula NOTE: Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/apps/cfmx/apps/common/Portal/index.cfm
  • Aspartate aminotransferase (AST) (SGOT) ≤5 x upper limit of normal (ULN).
  • alanine aminotransferase (ALT) (SGPT) ≤5 x ULN.
  • alkaline phosphatase ≤5 x ULN.
  • Total bilirubin ≤2.5 x ULN (if the participant is receiving atazanavir, a total bilirubin of ≤5 x ULN is acceptable).
  • Hemoglobin A1C ≤6.5%
  • +4 more criteria

You may not qualify if:

  • Change in the ART regimen within the 12 weeks prior to study entry, or anticipated/intended modification of ART during the study period.
  • Two or more HIV-1 RNA determinations \>200 copies/mL within the 48 week period prior to study entry.
  • History of clinical pancreatitis or diabetes mellitus diagnosed by a medical provider.
  • Acute or chronic liver disease with evidence of cirrhosis or portal hypertension.
  • Chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
  • History of chronic hepatitis B (defined as surface antibody negative, surface antigen positive, and/or HBV DNA detectable).
  • Use of any immunomodulator, HIV vaccine, investigational therapy, or anti-TNF therapies within 90 days prior to study entry.
  • Active malignancy with expected need for systemic chemotherapy or radiation therapy during the study period.
  • Use of human growth hormone, tesamorelin, testosterone or anabolic steroids within 90 days prior to study entry (except chronic, stable, replacement dosages in men with diagnosed hypogonadism is allowed).
  • Pregnant or breastfeeding.
  • Use of any anti-diabetic medication or GLP-1 analogues within the 12 weeks prior to study entry.
  • Current diagnosis of congestive heart failure.
  • Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Southern California (1201)

Los Angeles, California, 90033-1079, United States

Location

UCLA CARE Center CRS (601)

Los Angeles, California, 90095, United States

Location

Harbor-UCLA Med. Ctr. CRS (603)

Torrance, California, 90502, United States

Location

Whitman Walker Health CRS (31791)

Washington D.C., District of Columbia, 20009, United States

Location

Washington University CRS (2101)

St Louis, Missouri, 63110, United States

Location

Cornell CRS (7804)

New York, New York, 10011, United States

Location

Columbia Physicians and Surgeons CRS (30329)

New York, New York, 10032, United States

Location

University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)

Rochester, New York, 14642, United States

Location

Unc Aids Crs (3201)

Chapel Hill, North Carolina, 27516, United States

Location

Greensboro CRS (3203)

Greensboro, North Carolina, 27401, United States

Location

Univ. of Cincinnati CRS (2401)

Cincinnati, Ohio, 45267, United States

Location

Case CRS (2501)

Cleveland, Ohio, 44106, United States

Location

The Ohio State Univ. AIDS CRS (2301)

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS (6201)

Philadelphia, Pennsylvania, 19104, United States

Location

Pittsburgh CRS (1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

Houston AIDS Research Team CRS (31473)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
ACTG Clinicaltrials.gov Coordinator
Organization
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
ACTGCT.Gov@s-3.com
(301) 628-3313

Study Officials

  • Michael Dube, MD

    University of Southern California

    STUDY CHAIR

  • Kevin Yarasheski, PhD

    Washington University School of Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

August 3, 2015

Study Start

September 1, 2015

Primary Completion

December 13, 2016

Study Completion

January 10, 2017

Last Updated

June 18, 2018

Results First Posted

January 5, 2018

Record last verified: 2018-05

Locations

US(16)