Trial Outcomes & Findings for Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People (NCT NCT00919724)

NCT ID: NCT00919724

Last Updated: 2014-07-15

Results Overview

The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.

Recruitment status

COMPLETED

Target enrollment

89 participants

Primary outcome timeframe

Single measurement

Results posted on

2014-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	HIV-Infected HIV-infected participants who are not currently receiving antiretroviral medications	HIV-Uninfected HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
Overall Study STARTED	45	44
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV-Infected n=45 Participants HIV-infected participants who are not currently receiving antiretroviral medications	HIV-Uninfected n=44 Participants HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants	Total n=89 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	35 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	14 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	30 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Single measurement

Outcome measures

Outcome measures
Measure	HIV-Infected n=45 Participants HIV-infected participants who are not currently receiving antiretroviral medications	HIV-Uninfected n=44 Participants HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
Endothelial Function (Brachial Artery Reactivity)	3.98 percent dilation Standard Deviation 2.95 • Interval 1.91 to 4.99	3.37 percent dilation Standard Deviation 2.74 • Interval 1.2 to 4.59

Adverse Events

HIV-Infected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-Uninfected

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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