A Phase 1 interventional study of Etravirine in Endothelial Function, Lipids and Insulin Resistance, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-07.
Sponsored by Indiana University · Phase 1 and Interventional
The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two one-hundred mg tablets orally twice daily for four weeks
Also known as: INTELENCETM
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.
Time frame: Entry and four weeks
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
Recruitment occurred between April 2009 and March 2010. Participants were recruited via advertisements and word-of-mouth.
| Milestone | Etravirine |
|---|---|
| Started | 28 |
| Completed | 23 |
| Not completed | 5 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lost to follow-up | 3 |
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.
| Percentage | Etravirine |
|---|---|
| Flow-mediated Dilation (FMD) of the Brachial Artery | 0.03 (-3.21 to 0.97) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Six weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etravirine | — | 0/28 (0%) | 15/28 (53.6%) |
| Event | Etravirine |
|---|---|
| HeadacheNervous system disorders | 4/28 |
| ConstipationGastrointestinal disorders | 3/28 |
| Neuropathic tingling or painNervous system disorders | 2/28 |
| RashSkin and subcutaneous tissue disorders | 2/28 |
| DiarrheaGastrointestinal disorders | 2/28 |
| Nausea/vomitingGastrointestinal disorders | 2/28 |
| DizzinessNervous system disorders | 2/28 |
| Age, Categorical(Participants) | Etravirine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 0 |
| Age Continuous(years) | Etravirine |
|---|---|
| Median | 40 (28 to 47) |
| Sex: Female, Male(Participants) | Etravirine |
|---|---|
| Female | 13 |
| Male | 15 |
| Region of Enrollment(participants) | Etravirine |
|---|---|
| United States | 28 |
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Indiana University