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CompletedNCT00871234Updated Jan 7, 2011Results posted

Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study

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

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Endothelial Function
  • Lipids
  • Insulin Resistance
  • Inflammation
  • HIV Infections

Keywords

  • HIV
  • Endothelial function
  • Etravirine
03

In context

Insulin Resistance

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 18 years of age or older
  2. Negative ELISA for HIV-1 or HIV-2 at screening
  3. Negative hepatitis B surface antigen at screening
  4. Negative hepatitis C antibody at screening
  5. 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
  6. No history of diabetes, hypertension, or dyslipidemia
  7. No anticipated changes or additions to other medical therapies during the course of the study

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide written, informed consent
  2. Known allergy/intolerance to etravirine or nitroglycerin
  3. Absolute neutrophil count \< 750cell/mL at screening
  4. Hemoglobin \<11g/dL at screening
  5. Platelet count \<100,000/mL at screening
  6. Estimated creatinine clearance (per Cockcroft-Gault equation) \<55 mL/min at screening
  7. Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening
  8. Breastfeeding at screening and during the course of the study
  9. Hypotension, defined as SBP\<90mmHg at time of each main study visit before brachial artery ultrasound measurements
  10. 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
  11. Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
  12. Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
  13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  14. 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
  15. History of migraine headaches
  16. History of Raynaud's phenomenon
  17. History of cardiac arrythmias
  18. History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
  19. History of carotid bruits.
  20. History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within one year of screening.
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Interventions

  • DrugEtravirine

    Two one-hundred mg tablets orally twice daily for four weeks

    Also known as: INTELENCETM

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Lipid Fractions

    Time frame: Four weeks

  2. Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]

    Time frame: Four weeks

  3. Blood Pressure

    Time frame: Four weeks

  4. Inflammatory Biomarkers

    Time frame: Four weeks

  5. Endothelial Activation Biomarkers

    Time frame: Four weeks

07

Results

Posted Jan 5, 2011

Participant flow

Recruitment occurred between April 2009 and March 2010. Participants were recruited via advertisements and word-of-mouth.

Participant flow — Overall Study
MilestoneEtravirine
Started28
Completed23
Not completed5
Withdrew: Adverse event2
Withdrew: Lost to follow-up3

Outcome measures

PrimaryFlow-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
Reported as:
Median · Percentage
Flow-mediated Dilation (FMD) of the Brachial Artery
PercentageEtravirine
Flow-mediated Dilation (FMD) of the Brachial Artery0.03 (-3.21 to 0.97)
Statistical analysis
  • Etravirine · Wilcoxon signed-rank · p = 0.36 · Median difference (net): 0.03
SecondaryLipid Fractions
Time frame:
Four weeks

Results for this outcome have not been posted.

SecondaryInsulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]
Time frame:
Four weeks

Results for this outcome have not been posted.

SecondaryBlood Pressure
Time frame:
Four weeks

Results for this outcome have not been posted.

SecondaryInflammatory Biomarkers
Time frame:
Four weeks

Results for this outcome have not been posted.

SecondaryEndothelial Activation Biomarkers
Time frame:
Four weeks

Results for this outcome have not been posted.

Adverse events

Collected over Six weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Etravirine—0/28 (0%)15/28 (53.6%)
Most frequent other events
Most frequent other events
EventEtravirine
HeadacheNervous system disorders4/28
ConstipationGastrointestinal disorders3/28
Neuropathic tingling or painNervous system disorders2/28
RashSkin and subcutaneous tissue disorders2/28
DiarrheaGastrointestinal disorders2/28
Nausea/vomitingGastrointestinal disorders2/28
DizzinessNervous system disorders2/28

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Etravirine
<=18 years0
Between 18 and 65 years28
>=65 years0
Age Continuous
Age Continuous(years)Etravirine
Median40 (28 to 47)
Sex: Female, Male
Sex: Female, Male(Participants)Etravirine
Female13
Male15
Region of Enrollment
Region of Enrollment(participants)Etravirine
United States28
08

Study locations

1 site
  • Infectious Diseases Research Center
    Indianapolis, Indiana 46202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00871234
Lead sponsor
Indiana University
Collaborators
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
First posted
Mar 30, 2009
Start date
Apr 2009
Primary completion
Mar 2010
Completion
Jul 2010
Results posted
Jan 5, 2011
Last update
Jan 7, 2011

Study contacts

Samir K Gupta, MD, MS
principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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