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J Clin Endocrinol Metab. 2013 Feb;98(2):743-51. doi: 10.1210/jc.2012-3532. Epub 2012 Dec 21.

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

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1
Department of Internal Medicine, Washington University School of Medicine, St Louis, Missouri 63110, USA.

Abstract

CONTEXT:

People 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.

OBJECTIVE:

DPP4 inhibition will not reduce CD4+ T lymphocyte number or increase HIV viremia in HIV-positive adults.

DESIGN:

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

SETTING:

The study was conducted at an academic medical center.

PARTICIPANTS:

Twenty 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.

INTERVENTION:

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

MAIN OUTCOME MEASURES:

CD4+ 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.

RESULTS:

Compared 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.

CONCLUSIONS:

Despite 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.

PMID:
23264399
PMCID:
PMC3565112
DOI:
10.1210/jc.2012-3532
[Indexed for MEDLINE]
Free PMC Article
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