Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Insulin Resistance Clinical Trial

Official title:

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203461
• Other study ID #: STR-1383--0030-I
• Secondary ID: 2014-000359-98
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2014
• Last updated: November 4, 2014
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.

Description:

The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers, age 18-40 years

• Informed consent and willingness in study participation

• Birth control during study period

Exclusion Criteria:

• Participation in other clinical trials

• Contraindication or known allergy to study medication

• Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others

• Known alcohol or nicotine abuse

• HIV infection

• History of pharmaceutical study in the last 4 weeks

• BMI < 18 > 25

• Long-term or regular medication

• Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder

• Dependence to study center or coordinator

• Inmates or psychiatric treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
STRIBILD® QD, d1-14
• Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Truvada®/ Kaletra® 200/50 mg QD, d1-14
• Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14

Locations

Country	Name	City	State
Germany	University Hospital Klinikum rechts der Isar (TUM)	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	Gilead Sciences, MUC Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp	Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.	Day 14	Yes
Secondary	Changes in metabolic parameters	Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.	Day 14	No

External Links

•   Related Center information