Phase 3
N=38
Effectiveness of Sitagliptin for HIV Insulin Resistance and Inflammation
Inflammation · Macrophage Infiltration · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01552694 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Inflammatory Biomarker 1: Plasma hsCRP Concentration — 3.4; 5.4; 2.9; 7.4 mg/L — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sitagliptin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammatory Biomarker 1: Plasma hsCRP Concentration |
3.4; 5.4; 2.9; 7.4 | 0.006 sig |
| PRIMARY Inflammatory Biomarker 2: Plasma IL-6 Concentration |
1.36; 2.61; 1.30; 2.65 | 0.24 |
| PRIMARY Inflammatory Biomarker 3: Serum D-dimer Concentration |
0.32; 0.28; 0.33; 0.31 | 0.78 |
| SECONDARY Fold Change in Adipose Inflammation Marker CCL2 (MCP-1) mRNA Expression |
-2.5; -0.4 | — |
| SECONDARY Percent Change in Blood Endothelial Progenitor Cells |
0.3; -0.2 | — |
Summary
People living with human immunodeficiency virus infection (HIV) have 2-4fold greater risk for developing diabetes and heart disease than the general population. They need safe and effective treatments that reduce the risk for developing diabetes and heart disease, and improve their quality of life. This project will explore whether a new anti-diabetes medication (Januvia) with a novel mechanism of action reduces inflammation, and improves blood vessel function in HIV infected men and women with several risk factors for developing cardiovascular disease.
Eligibility Criteria
Inclusion Criteria
- 18-65 yr old HIV infected men and women.
- Stable (at least the past 6 months) on combined antiretroviral therapy (cART).
- Stable immune (> 300 CD4+ T-cells/µL) and virologic ( 102 cm (men), > 88 cm (women).
- BMI > 20 kg/m2.
- Fasting hypertriglyceridemia > 150 mg/dL.
- Low HDL-cholesterol ( 30,000/mm3.
- Absolute neutrophil count > 750/mm3.
- Transaminases 160/95 mmHg), irregular heart rhythm, resting ST-segment depression > 1mm). Treatment with medications for CV condition (e.g., α- or ß-blockers). Some BP-lowering medications (Ca++channel blocker, diuretic, or ACE inhibitor) are permitted.
- Moderate to severe renal insufficiency. Serum creatinine > 1.7 mg/dL (men) > 1.5 mg/dL (women).
- Plan or anticipate a change in anti-HIV medications during the study.
- Lipid-lowering medications are permitted (fibrate or statin or niacin), but must be stable on that agent for at least 6 months prior to enrollment. Lipid-lowering agents cannot be started during the treatment period.
- Chronic hepatitis B (HBV-surface antigen positive). Active hepatitis C (detectable Hep C RNA).
- Positive urine drug test for opiates, methamphetamine, heroin, cocaine. Active substance abuse that the MD-scientist believes may compromise safety, compliance, interfere with study drug or data interpretation.
- Hematocrit 10% unintentional weight loss during the 6 months prior to enrollment.
- Reduced cognitive function/unable to provide voluntary informed consent. Prisoners are excluded.
- Blinded investigational drugs for 3 months prior to enrollment that will not be unblinded before enrollment.
- Nausea, vomiting, diarrhea (> 4 loose stools/day) that are unresponsive to treatment.
Data sourced from ClinicalTrials.gov (NCT01552694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.