Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02203461

Enrollment

Registered

2014-07-30

Start date

2014-07-31

Completion date

2014-10-31

Last updated

2014-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

ART, HIV, insulin resistance

Brief 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.

Detailed 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).

Interventions

DRUGTenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

STRIBILD® QD, d1-14

DRUGTenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

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

DRUGTenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp	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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026