Trial Outcomes & Findings for Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study (NCT NCT00871234)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Entry and four weeks

Results posted on

2011-01-07

Participant Flow

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

After participant enrollment, a screening visit was performed to determine eligibility. Participants may have been excluded from entering the study if they were found to be ineligible.

Participant milestones

Participant milestones
Measure	Etravirine Healthy volunteers receiving etravirine 200mg orally twice daily
Overall Study STARTED	28
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Etravirine Healthy volunteers receiving etravirine 200mg orally twice daily
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etravirine n=28 Participants Healthy volunteers receiving etravirine 200mg orally twice daily
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	40 years n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Region of Enrollment United States	28 participants n=99 Participants

PRIMARY outcome

Timeframe: Entry and four weeks

Population: FMD analysis was per protocol restricted to those who completed the four week trial. The safety analysis was ITT.

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.

Outcome measures

Outcome measures
Measure	Etravirine n=28 Participants Healthy volunteers receiving etravirine 200mg orally twice daily
Flow-mediated Dilation (FMD) of the Brachial Artery	0.03 Percentage Interval -3.21 to 0.97

SECONDARY outcome

Timeframe: Four weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Four weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Four weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Four weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Four weeks

Outcome measures

Outcome data not reported

Adverse Events

Etravirine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Etravirine n=28 participants at risk Healthy volunteers receiving etravirine 200mg orally twice daily
Nervous system disorders Neuropathic tingling or pain	7.1% 2/28 • Number of events 2 • Six weeks
Skin and subcutaneous tissue disorders Rash	7.1% 2/28 • Number of events 2 • Six weeks
Gastrointestinal disorders Diarrhea	7.1% 2/28 • Number of events 2 • Six weeks
Gastrointestinal disorders Nausea/vomiting	7.1% 2/28 • Number of events 2 • Six weeks
Gastrointestinal disorders Constipation	10.7% 3/28 • Number of events 3 • Six weeks
Nervous system disorders Headache	14.3% 4/28 • Number of events 4 • Six weeks
Nervous system disorders Dizziness	7.1% 2/28 • Number of events 2 • Six weeks

Additional Information

Samir K. Gupta, MD, MS

Indiana University School of Medicine

Phone: 317-274-7926

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place