Insulin ResistancePhase 1NCT02203461
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
A Phase 1 study testing Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat, Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir and Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir in people with Insulin Resistance, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat, Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir and Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, age 18-40 years
- Informed consent and willingness in study participation
- Birth control during study period
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Klinikum rechts der Isar (TUM)
Munich, Bavaria, 81675
About this study
Official title: Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.
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.
Read the 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).
- Conditions
- Insulin Resistance
- Being tested
- Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat, Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir, Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
- Keywords
- ART, HIV, insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistatDrug
Also called STRIBILD®
STRIBILD® QD, d1-14
Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavirDrug
Also called Truvada® / Kaletra®
Truvada®/ Kaletra® 200/50 mg QD, d1-14
Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavirDrug
Also called Truvada®/Prezista®/Norvir®
Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat Receives: Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat |
| Group II | Active comparator | Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir Receives: Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir |
| Group III | Experimental | Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir Receives: Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (1)
Changes in metabolic parameters
Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, MUC Research GmbH
- Responsible party
- Sponsor
- Investigators
- Christoph D Spinner, MD, Principal investigator, University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203461
- Sponsor's protocol ID
- STR-1383--0030-I
- Other IDs
- 2014-000359-98, 2014
- Status last verified
- Nov 2014
- First submitted
- 28 Jul 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.
- ClinicalTrials.gov ID
- NCT02203461
- Acronym / sponsor ID
- STR-1383--0030-I
- Conditions
- Insulin Resistance
- Keywords
- ART, HIV, insulin resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Gilead Sciences, MUC Research GmbH
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistatSTRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat |
| Group II | Active comparator | Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavirTruvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir |
| Group III | Experimental | Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavirTruvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers, age 18-40 years
- Informed consent and willingness in study participation
- Birth control during study period
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistatAlso: STRIBILD®STRIBILD® QD, d1-14 | Drug | Group I |
| Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavirAlso: Truvada® / Kaletra®Truvada®/ Kaletra® 200/50 mg QD, d1-14 | Drug | Group II |
| Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavirAlso: Truvada®/Prezista®/Norvir®Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14 | Drug | Group III |
Primary outcome
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.
1 secondary outcome
Changes in metabolic parameters
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph D Spinner, MD principal investigator
University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat, Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir and Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir in people with Insulin Resistance, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.