Trial Outcomes & Findings for A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease (NCT NCT01578772)

Results Overview

Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

6 weeks (after baseline)

Results posted on

2014-12-08

Participant milestones
Measure	Telmisartan Open label Telmisartan: 80mg tablets po daily for 6 weeks
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Withdrawal data not reported

A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease

Baseline characteristics by cohort
Measure	Telmisartan n=17 Participants Open label Telmisartan: 80mg tablets po daily for 6 weeks
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

Timeframe: 6 weeks (after baseline)

Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.

Outcome measures
Measure	Baseline (Week 0) n=17 Participants All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.	Week 6 n=17 Participants All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy Brachial Artery Diameter	4.6 mm Interval 4.4 to 4.9	4.7 mm Interval 4.4 to 5.1
6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy Maximum Absolute FMD	0.1 mm Interval 0.1 to 0.2	0.2 mm Interval 0.1 to 0.3

Timeframe: 6 weeks (after baseline)

Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.

Outcome measures
Measure	Baseline (Week 0) n=17 Participants All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.	Week 6 n=17 Participants All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy	2.7 percentage of maximum relative FMD Interval 1.4 to 3.9	3.5 percentage of maximum relative FMD Interval 1.6 to 6.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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