Conditions: HIV-1 Infection
Keywords: Sitagliptin Inflammation Immune activation Viral suppression HIV-1 Immunology biomarkers sCD14
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

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.

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).

Arms:
arm 1: Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up. arm 2: Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.

Interventions: intervention 1: Sitagliptin intervention 2: Placebo for sitagliptin
Intervention descriptions: intervention 1: 100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up intervention 2: One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.

Protocol document: