drugset / Trial / NCT03092206

Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication

NCT03092206 ↗

Phase 1 Completed 30 enrolled Technical University of Munich
RandomizedParallel-groupOpen-labelTreatment

Summary

Investigation of possible changes in insulin sensitivity in healthy volunteers taking the following HIV treatment combinations: F/TAF (group 1) as compared to E/C/F/TAF (group 2) as compared to R/F/TAF (group 3). The measurement of insulin sensitivity will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14±2 days of treatment. The volunteers will be randomly assigned to one of the three groups. Changes in insulin sensitivity will be measured by golden standard hyperinsulinemic euglycemic clamp (HEGC) technique, using glucose and insulin infusion as diagnostic agents

Timeline

Start
2017-04-18
Primary completion
2017-07-28
Completion
2017-07-28

Drugs

EvaluationDrugModalityDoseRoute
Subject E/C/F/TAF Unknown — Oral
Subject F/TAF Unknown — Oral
Subject R/F/TAF Unknown — Oral

Indications

No indication recorded.