Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

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.

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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).

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Group Type EXPERIMENTAL

Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Intervention Type DRUG

STRIBILD® QD, d1-14

Group II

Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Group Type ACTIVE_COMPARATOR

Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Intervention Type DRUG

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

Group III

Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

Group Type EXPERIMENTAL

Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

Intervention Type DRUG

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

Interventions

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Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

STRIBILD® QD, d1-14

Intervention Type DRUG

Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

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

Intervention Type DRUG

Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

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

Intervention Type DRUG

Other Intervention Names

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STRIBILD® Truvada® / Kaletra® Truvada®/Prezista®/Norvir®

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes