NCT00871234

Brief Summary

The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 5, 2011

Completed
Last Updated

January 7, 2011

Status Verified

December 1, 2010

Enrollment Period

11 months

First QC Date

March 27, 2009

Results QC Date

December 7, 2010

Last Update Submit

January 5, 2011

Conditions

Endothelial FunctionLipidsInsulin ResistanceInflammationHIV Infections

Keywords

HIVEndothelial functionEtravirine

Outcome Measures

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.

    Entry and four weeks

Secondary Outcomes (5)

  • Lipid Fractions

    Four weeks

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

    Four weeks

  • Blood Pressure

    Four weeks

  • Inflammatory Biomarkers

    Four weeks

  • Endothelial Activation Biomarkers

    Four weeks

Interventions

EtravirineDRUG

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

Also known as: INTELENCETM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Insulin ResistanceInflammationHIV Infections

Interventions

etravirine

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Samir K. Gupta, MD, MS
Organization
Indiana University School of Medicine
sgupta1@iupui.edu
317-274-7926

Study Officials

  • Samir K Gupta, MD, MS

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

January 7, 2011

Results First Posted

January 5, 2011

Record last verified: 2010-12

Locations

US(1)