HIV-1 InfectionPhase 2NCT02513771

Sitagliptin for Reducing Inflammation and Immune Activation

A Phase 2 study testing Sitagliptin in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 16 sitesUnited States
Study dates: Sep 2015to 10 Jan 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 19Show fewer

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%
For females of reproductive potential, adequate contraception.
Karnofsky performance score ≥70 within 90 days prior to entry.
Ability and willingness of participant or legal guardian/representative to provide informed consent.
Participants on statin therapy must be stable on the same dose for at least the prior 12 weeks with no anticipated change in statin or dose during the intervention.

Who cannot join

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).

Show all 15Show fewer

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.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Unc Aids Crs (3201)
Chapel Hill, North Carolina, 27516
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, 45267
Case CRS (2501)
Cleveland, Ohio, 44106
The Ohio State Univ. AIDS CRS (2301)
Columbus, Ohio, 43210
Greensboro CRS (3203)
Greensboro, North Carolina, 27401
Houston AIDS Research Team CRS (31473)
Houston, Texas, 77030
University of Southern California (1201)
Los Angeles, California, 90033-1079
UCLA CARE Center CRS (601)
Los Angeles, California, 90095
Cornell CRS (7804)
New York, New York, 10011
Columbia Physicians and Surgeons CRS (30329)
New York, New York, 10032
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, 19104
Pittsburgh CRS (1001)
Pittsburgh, Pennsylvania, 15213
University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)
Rochester, New York, 14642
Washington University CRS (2101)
St Louis, Missouri, 63110
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, 90502
Whitman Walker Health CRS (31791)
Washington D.C., District of Columbia, 20009

Other trials in United States

About this study

Official title: 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)

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.

Read the 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
Being tested: Sitagliptin, Placebo for sitagliptin
Keywords: Sitagliptin, Inflammation, Immune activation, Viral suppression, HIV-1, Immunology biomarkers, sCD14
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitagliptinDrug
Also called Januvia
100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up
Placebo for sitagliptinDrug
Also called Placebo
One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.

Study groups in NCT02513771
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo for sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pre-entry, Week 0, Week 15, Week 16

Secondary outcomes (15)

Change in sCD14 From Week 15/16 to Week 20
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 week 15/16 to week 20 (week 20 - week 15/16).
Levels measured at week 15 and week 16 were averaged for week 15/16.
Measured: Week 15, week 16, week 20
Change in sCD163
sCD163 (soluble CD 163) is a marker of macrophage activation and arterial inflammation.
Change in log10 transformed sCD163 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in sCD26
sCD26 (soluble cluster of differentiation 26) is an enzyme that metabolizes DPP-4 (dipeptidyl peptidase-4), an enzyme that is inhibited by sitagliptin.
Change in log10 transformed sCD26 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in IL-6
IL-6 (Interleukin-6) is a biomarker of systemic inflammation. Change in log10 transformed IL-6 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in hsCRP
hsCRP (high-sensitivity C-reactive protein) is a biomarker of inflammation. Change in log10 transformed hsCRP from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in sTNF-r1
sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a biomarker of inflammation.
Change in log10 transformed sTNF-r1 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in sTNF-r2
sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a biomarker of inflammation.
Change in log10 transformed sTNF-r2 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in IP-10
IP-10 (also known as CXCL10) is a biomarker implicated in cardiovascular disease.
Change in log10 transformed IP-10 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).
Measured: Week 0, week 15, week 20
Change in CD4+/CD8+ T-cell Ratio
CD4+/CD8+ T-cell ratio change from week 0 to week 15 (week 15 - week 0). Note that CD4 and CD8 were not evaluated at week 20 in this study.
Measured: Week 0 and week 15
Change in CD4+ T-cell Activation
Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.
The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).
Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.
Measured: Week 0, week 15, week 20
Change in CD8+ T-cell Activation
Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.
The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).
Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.
Measured: Week 0, week 15, week 20
Change in %CD14+/CD16- (Classical Monocytes)
CD14+/CD16- is the percentage of cells that expressed CD14 and low CD16 in total monocytes (also known as classical monocytes).
This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).
Data for cellular markers are not available as of November 2017. The study team prioritized completion of the soluble markers (including the primary outcome measure), which are reported herein, over the completion of the cellular markers. Results will be entered once the data is complete and analyzed.
Measured: Week 0, week 15, week 20
Change in %CD14+/CD16+ (Intermediate Monocytes)
%CD14+/CD16+ is the percentage of cells that expressed both CD14 and CD16 in total monocytes (also known as intermediate monocytes).
This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).
Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.
Measured: Week 0, week 15, week 20
Change in %CD14dim/CD16++ (Non-classical Monocytes)
%CD14dim/CD16++ is the percentage of cells that expressed low levels of CD14dim and high levels of CD16++ in total monocytes (also known as non-classical monocytes).
This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).
Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed.
Measured: Week 0, week 15, week 20
Number of Participants With Grade ≥2 Adverse Events Related to Study Drug
The DAIDS Adverse Event Grading Table, Version 2.0, was used for grading of AEs
Measured: From study entry to end of study (Week 20)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201510 Jan 2017

First posted3 Aug 2015 (estimated)
Study startSep 2015
Primary completion13 Dec 2016
Study completion10 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02513771
Sponsor's protocol ID: ACTG A5346
Other IDs: UM1AI068636
Status last verified: May 2018
First submitted: 13 Jul 2015
Last updated: 18 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02513771
Acronym / sponsor ID: ACTG A5346
Conditions: HIV-1 Infection
Keywords: Sitagliptin, Inflammation, Immune activation, Viral suppression, HIV-1, Immunology biomarkers, sCD14
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Sep 2015
Primary completion: 13 Dec 2016 (actual)
Study completion: 10 Jan 2017 (actual)
First posted: 3 Aug 2015 (estimated)
Results: Posted 5 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Sitagliptin Arm	Active comparator	Drug: SitagliptinSitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up.
Placebo Arm	Placebo comparator	Drug: Placebo for sitagliptinPlacebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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.

Key exclusion criteria (15 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SitagliptinAlso: Januvia100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up	Drug	Sitagliptin Arm
Placebo for sitagliptinAlso: PlaceboOne tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.	Drug	Placebo Arm

Primary outcome

Change in sCD14 From Baseline to Week 15/16
Time frame: Pre-entry, Week 0, Week 15, Week 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.

15 secondary outcomes

Change in sCD14 From Week 15/16 to Week 20
Time frame: Week 15, week 16, week 20
Change in sCD163
Time frame: Week 0, week 15, week 20
Change in sCD26
Time frame: Week 0, week 15, week 20
Change in IL-6
Time frame: Week 0, week 15, week 20
Change in hsCRP
Time frame: Week 0, week 15, week 20
Change in sTNF-r1
Time frame: Week 0, week 15, week 20
Change in sTNF-r2
Time frame: Week 0, week 15, week 20
Change in IP-10
Time frame: Week 0, week 15, week 20
Change in CD4+/CD8+ T-cell Ratio
Time frame: Week 0 and week 15
Change in CD4+ T-cell Activation
Time frame: Week 0, week 15, week 20
Change in CD8+ T-cell Activation
Time frame: Week 0, week 15, week 20
Change in %CD14+/CD16- (Classical Monocytes)
Time frame: Week 0, week 15, week 20
Change in %CD14+/CD16+ (Intermediate Monocytes)
Time frame: Week 0, week 15, week 20
Change in %CD14dim/CD16++ (Non-classical Monocytes)
Time frame: Week 0, week 15, week 20
Number of Participants With Grade ≥2 Adverse Events Related to Study Drug
Time frame: From study entry to end of study (Week 20)

Results and safety

Results posted to the registry on 5 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin Arm	45	43
Placebo Arm	45	44

Primary outcome: Change in sCD14 From Baseline to Week 15/16

Time frame: Pre-entry, Week 0, Week 15, Week 16. Median (Inter-Quartile Range). Unit: log10 pg/mL

Measure	Sitagliptin Arm n = 42	Placebo Arm n = 42
Value	-0.03 (-0.06 to 0.02)	-0.03 (-0.08 to 0.02)

Sitagliptin Arm vs Placebo Arm: p = 1.000, Wilcoxon (Mann-Whitney)

Population analysed: As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) reported from first dose of study treatment until study completion at 20 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	1 of 45 (2.2%)	20 of 45 (44.4%)	0 of 45
Placebo	2 of 45 (4.4%)	24 of 45 (53.3%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Dube, MD study chair

University of Southern California

Kevin Yarasheski, PhD study chair

Washington University School of Medicine

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitagliptin in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sCD14 From Baseline to Week 15/16 (time frame: Pre-entry, Week 0, Week 15, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02513771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.