Endothelial FunctionPhase 1NCT00871234
Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study
A Phase 1 study testing Etravirine in people with Endothelial Function and Lipids, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function, Lipids, Insulin Resistance
- What is being tested?
- Etravirine
- Type of treatment
- Pill or oral medicine
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Negative ELISA for HIV-1 or HIV-2 at screening
- Negative hepatitis B surface antigen at screening
- Negative hepatitis C antibody at screening
- For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study
- No history of diabetes, hypertension, or dyslipidemia
- No anticipated changes or additions to other medical therapies during the course of the study
Who cannot join
- Inability to provide written, informed consent
- Known allergy/intolerance to etravirine or nitroglycerin
- Absolute neutrophil count < 750cell/mL at screening
- Hemoglobin <11g/dL at screening
- Platelet count <100,000/mL at screening
- Estimated creatinine clearance (per Cockcroft-Gault equation) <55 mL/min at screening
Show all 20Show fewer
- Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening
- Breastfeeding at screening and during the course of the study
- Hypotension, defined as SBP<90mmHg at time of each main study visit before brachial artery ultrasound measurements
- Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (>10mg/day of prednisone or the equivalent), or anabolic steroids within 30 days of each screening visit or each main study visit
- Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
- Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to each screening and study visit
- History of migraine headaches
- History of Raynaud's phenomenon
- History of cardiac arrythmias
- History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
- History of carotid bruits.
- History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within one year of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Infectious Diseases Research Center
Indianapolis, Indiana, 46202
About this study
Official title: Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study
The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.
Read the detailed description
We hypothesize that in HIV-uninfected subjects, etravirine 200mg twice daily for four weeks will have no effect on endothelial function. The primary objective of this study is to determine the effects of etravirine 200mg twice daily given for four weeks on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery, in HIV-uninfected subjects. Secondary objectives include determination of the effects of etravirine 200mg twice daily given for four weeks on safety measures, lipid fractions, HOMA-IR, blood pressure, inflammatory parameters, and endothelial activation parameters.
- Conditions
- Endothelial Function, Lipids, Insulin Resistance, Inflammation, HIV Infections
- Being tested
- Etravirine
- Keywords
- HIV, Endothelial function, Etravirine
- Medical subject headings
- Insulin Resistance, Inflammation, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtravirineDrug
Also called INTELENCETM
Two one-hundred mg tablets orally twice daily for four weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated Dilation (FMD) of the Brachial Artery
FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.
Measured: Entry and four weeks
Secondary outcomes (5)
Lipid Fractions
Measured: Four weeks
Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]
Measured: Four weeks
Blood Pressure
Measured: Four weeks
Inflammatory Biomarkers
Measured: Four weeks
Endothelial Activation Biomarkers
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Investigators
- Samir K Gupta, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871234
- Sponsor's protocol ID
- 0812-18 (TMC125HIV4003)
- Status last verified
- Dec 2010
- First submitted
- 27 Mar 2009
- Last updated
- 7 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT00871234
- Acronym / sponsor ID
- 0812-18 (TMC125HIV4003)
- Conditions
- Endothelial Function, Lipids, Insulin Resistance, Inflammation, HIV Infections
- Keywords
- HIV, Endothelial function, Etravirine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 5 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.
Detailed description
We hypothesize that in HIV-uninfected subjects, etravirine 200mg twice daily for four weeks will have no effect on endothelial function. The primary objective of this study is to determine the effects of etravirine 200mg twice daily given for four weeks on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery, in HIV-uninfected subjects. Secondary objectives include determination of the effects of etravirine 200mg twice daily given for four weeks on safety measures, lipid fractions, HOMA-IR, blood pressure, inflammatory parameters, and endothelial activation parameters.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Negative ELISA for HIV-1 or HIV-2 at screening
- Negative hepatitis B surface antigen at screening
- Negative hepatitis C antibody at screening
- For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study
Key exclusion criteria (20 listed)
- Inability to provide written, informed consent
- Known allergy/intolerance to etravirine or nitroglycerin
- Absolute neutrophil count < 750cell/mL at screening
- Hemoglobin <11g/dL at screening
- Platelet count <100,000/mL at screening
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 |
|---|---|---|
| EtravirineAlso: INTELENCETMTwo one-hundred mg tablets orally twice daily for four weeks | Drug | – |
Primary outcome
Flow-mediated Dilation (FMD) of the Brachial Artery
Time frame: Entry and four weeks
FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.
5 secondary outcomes
Lipid Fractions
Time frame: Four weeks
Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]
Time frame: Four weeks
Blood Pressure
Time frame: Four weeks
Inflammatory Biomarkers
Time frame: Four weeks
Endothelial Activation Biomarkers
Time frame: Four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samir K Gupta, MD, MS principal investigator
Indiana University
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 Etravirine in people with Endothelial Function and Lipids, run by Indiana University at 1 site in United States.
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 7 inclusion and 20 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 7 Jan 2011. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flow-mediated Dilation (FMD) of the Brachial Artery (time frame: Entry and four weeks). 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 7 Jan 2011.