Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
* Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
* Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat | Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat<br>* STRIBILD® QD, d1-14<br>* Other names: STRIBILD®;|
| Active Comparator: Group II<br>Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir | Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir<br>* Truvada®/ Kaletra® 200/50 mg QD, d1-14<br>* Other names: Truvada® / Kaletra®;|
| Experimental: Group III<br>Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir | Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir<br>* Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14<br>* Other names: Truvada®/Prezista®/Norvir®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic parameters | Changes in lipid, metabolic hormons and HOMA-IR, Homa-beta, QUICKIE test. | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ART, HIV, insulin resistance