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Completed

NCT Number: NCT02203461

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Klinikum rechts der Isar (TUM)

Munich, Bavaria, 81675, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Drug

STRIBILD® QD, d1-14

Other names: STRIBILD®

Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Drug

Truvada®/ Kaletra® 200/50 mg QD, d1-14

Other names: Truvada® / Kaletra®

Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

Drug

Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14

Other names: Truvada®/Prezista®/Norvir®

Primary outcomes

  1. Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp

    Time frame: Day 14

    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.

Secondary outcomes

  1. Changes in metabolic parameters

    Time frame: Day 14

    Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Gilead Sciences
  • MUC Research GmbH

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2014
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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