Evidence mapPaperPMID 23264399Full record

Trial reportThe Journal of clinical endocrinology and metabolism2013

Dipeptidyl peptidase IV inhibition does not adversely affect immune or virological status in HIV infected men and women: a pilot safety study.

Scott R Goodwin, Dominic N Reeds, Michael Royal, Heidi Struthers, Erin Laciny, Kevin E Yarasheski

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01093651 (A Blinded Randomized Controlled Pilot Immunologic and Virologic Safety Trial of an FDA-approved DPPIV-inhibitor in HIV+ Men and Women), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01093651 phase2 / phase3completednot on this map

A Blinded Randomized Controlled Pilot Immunologic and Virologic Safety Trial of an FDA-approved DPPIV-inhibitor in HIV+ Men and Women

TypeinterventionalSponsorWashington University School of MedicineRan2010 to 2012Enrolled20ConditionsDiabetes, Insulin ResistanceArmsSitagliptin, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
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  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Diabetes in People with HIV.Current diabetes reports · 2021
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Diabetes and HIV.Current diabetes reports · 2018
    Review
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Scott R GoodwinDepartment of Internal Medicine, Washington University School of Medicine, St Louis, Missouri 63110, USA.
Dominic N Reeds
Michael Royal
Heidi Struthers
Erin Laciny
Kevin E Yarasheski
Washington University in St. Louis · US

Funding

TRANSGENICS COREP60DK020579 · WASHINGTON UNIVERSITY · 1986 to 2005
$11.8M
Washington University Nutrition Obesity Research CenterP30DK056341 · WASHINGTON UNIVERSITY · 1999 to 2025
$5.7M
WU P&FP30DK020579 · NIDDK · WASHINGTON UNIVERSITY · 2022 to 2025
$5.6M
DIABETES &RELATED METABOLIC DISEASEST32DK007120 · WASHINGTON UNIVERSITY · 1986 to 2025
$3.4M
PROTEIN TURNOVER AND ANABOLIC INTERVENTIONS IN AIDSR01DK049393 · WASHINGTON UNIVERSITY · 1994 to 2005
$1.3M
NCATS NIH HHS UL1 TR000448NCRR NIH HHS RR024992NCRR NIH HHS UL1 RR024992NIAID NIH HHS AI069495NIAID NIH HHS U01 AI069495NIAID NIH HHS UM1 AI069495NIDDK NIH HHS DK020579NIDDK NIH HHS DK056341NIDDK NIH HHS P30 DK020579NIDDK NIH HHS P30 DK056341NIDDK NIH HHS P60 DK020579NIDDK NIH HHS R01 DK049393NIDDK NIH HHS T32 DK007120NIDDK NIH HHS T32DK007120NIGMS NIH HHS GM103422NIGMS NIH HHS P41 GM103422
6 · The paper itself

Abstract

contextPeople infected with HIV have a higher risk for developing insulin resistance, diabetes, and cardiovascular disease than the general population. Dipeptidyl peptidase IV (DPP4) inhibitors are glucose-lowering medications with pleiotropic actions that may particularly benefit people with HIV, but the immune and virological safety of DPP4 inhibition in HIV is unknown.

objectiveDPP4 inhibition will not reduce CD4+ T lymphocyte number or increase HIV viremia in HIV-positive adults.

designThis was a randomized, placebo-controlled, double-blind safety trial of sitagliptin in HIV-positive adults.

settingThe study was conducted at an academic medical center.

participantsTwenty nondiabetic HIV-positive men and women (9.8 ± 5.5 years of known HIV) taking antiretroviral therapy and with stable immune (625 ± 134 CD4+ T cells per microliter) and virological (<48 copies HIV RNA per milliliter) status.

interventionThe intervention included sitagliptin (100 mg/d) vs matching placebo for up to 24 weeks.

main outcome measuresCD4+ T cell number and plasma HIV RNA were measured every 4 weeks; fasting serum regulated upon activation normal T-cell expressed and secreted (RANTES), stromal derived factor (SDF)-1α, Soluble TNF receptor II, and oral glucose tolerance were measured at baseline, week 8, and the end of study. ANOVA was used for between-group comparisons; P < .05 was considered significant.

resultsCompared with placebo, sitagliptin did not reduce CD4+ T cell count, plasma HIV RNA remained less than 48 copies/mL, RANTES and soluble TNF receptor II concentrations did not increase. SDF1α concentrations declined (P < .0002) in the sitagliptin group. The oral glucose tolerance levels improved in the sitagliptin group at week 8.

conclusionsDespite lowering SDF1α levels, sitagliptin did not adversely affect immune or virological status, or increase immune activation, but did improve glycemia in healthy, nondiabetic HIV-positive adults. These safety data allow future efficacy studies of sitagliptin in HIV-positive people with cardiometabolic complications.

Indexed as

AdolescentAdultAgedCD4 Lymphocyte CountCD4-Positive T-LymphocytesDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodFemaleHIV InfectionsHIV SeropositivityHumansMaleMiddle AgedPilot ProjectsPyrazinesRNA, ViralDipeptidyl-Peptidase IV InhibitorsPyrazinesRNA, ViralSitagliptin PhosphateTriazoles

Identifiers

PMID23264399
PMCPMC3565112
OpenAlexW2059154143

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.