Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication

NCT03092206 | Completed Phase 1

• 1 other identifier: TAF-1688-0030-I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of possible changes in insulin sensitivity in healthy volunteers taking the following HIV treatment combinations: F/TAF (group 1) as compared to E/C/F/TAF (group 2) as compared to R/F/TAF (group 3). The measurement of insulin sensitivity will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14±2 days of treatment. The volunteers will be randomly assigned to one of the three groups. Changes in insulin sensitivity will be measured by golden standard hyperinsulinemic euglycemic clamp (HEGC) technique, using glucose and insulin infusion as diagnostic agents

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Changes in insulin sensitivity

  To assess changes in insulin sensitivity (mean glucose disposal rate normalized to body weight (MBW \[mg glucose/min\*kg\]) in HIV-negative, healthy, non-obese (BMI 18-25) male volunteers following 14±2 days of treatment with group 1 or group 2 or group 3, as measured by HEGC.

  14±2 days

Secondary Outcomes (2)

• changes in insulin sensitivity

  14 +/-2 days

• lipid metabolism

  14±2 days

Study Arms (3)

Group 1

EXPERIMENTAL

F/TAF ; oral; Dose: 25/200 mg; Frequency: QD

Drug: F/TAF

Group 2

EXPERIMENTAL

Group 2: E/C/F/TAF; oral; Dose: 150/150/200/10 mg; Frequency: QD

Drug: E/C/F/TAF

Group 3

EXPERIMENTAL

Group 3: R/F/TAF; oral; Dose: 25/200/25 mg; Frequency: QD

Drug: R/F/TAF

Interventions

F/TAF DRUG

antiretroviral therapy

Also known as: Descovy

Group 1

E/C/F/TAF DRUG

antiretroviral therapy

Also known as: Genvoya

Group 2

R/F/TAF DRUG

antiretroviral therapy

Also known as: Odefsey

Group 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, healthy volunteers, age range ≥18-40 years
• Written informed consent and willingness to attend study visits
• Willingness for taking study medication during study period
• Birth control during study period

You may not qualify if:

• Participation in other interventional clinical trials and/or participation in another clinical trial with medicinal products within the last 4 weeks
• Known allergies or contraindications against study medication
• Known metabolic dysfunction, e.g. Hypertriglyceridemia or Diabetes mellitus
• Smoking or alcohol abuse (\> 15g/day alcohol consumption)
• Documented HIV-infection
• BMI \<18 \>25
• Recurrent medication or any antiretroviral medication within the last 30 days
• ALT, AST, Bilirubin, Creatinine, TSH, blood pressure, heart rate, QTc are out of normal range
• o Normal ranges for clinical chemistry are defined by local laboratory. For blood pressure normal range is defined as 100/60-140/90; for heart rate 60-100
• Known liver, kidney, heart, pulmonary, gastrointestinal, endocrinological, rheumathoid, neurological, psychiatric or metabolic diseases
• Any situation of which the sponsors sees relevant contraindication against study participation
• Imprisoned or situated people

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar (IZAR)

Munich, 81675, Germany

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

emtricitabine tenofovir alafenamide; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: F/TAF ; oral; Dose: 25/200 mg; Frequency: QD Group 2: E/C/F/TAF; oral; Dose: 150/150/200/10 mg; Frequency: QD Group 3: R/F/TAF; oral; Dose: 25/200/25 mg; Frequency: QD

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: April 18, 2017
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)