Trial Outcomes & Findings for Artery Elasticity After Switch From Epzicom to Truvada (NCT NCT00998582)

Results Overview

Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

Change from baseline to 24 weeks

Results posted on

2012-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Abacavir Participants randomized to this arm will continue abacavir and their other HIV medications with no changes	Tenofovir Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Artery Elasticity After Switch From Epzicom to Truvada

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abacavir n=13 Participants Participants randomized to this arm will continue abacavir and their other HIV medications with no changes	Tenofovir n=14 Participants Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	47 years STANDARD_DEVIATION 7 • n=5 Participants	43 years STANDARD_DEVIATION 9 • n=7 Participants	46 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Small artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in small artery elasticity (mL/mmHg x100) from baseline to week 24

Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.

Outcome measures

Outcome measures
Measure	Abacavir n=13 Participants Participants randomized to this arm will continue abacavir and their other HIV medications with no changes	Tenofovir n=14 Participants Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24	0.2 ml/mmHg x100 Interval -0.5 to 2.3	-1.3 ml/mmHg x100 Interval -2.8 to 2.7

PRIMARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Large artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in large artery elasticity (mL/mmHg x10) from baseline to week 24

Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease.

Outcome measures

Outcome measures
Measure	Abacavir n=13 Participants Participants randomized to this arm will continue abacavir and their other HIV medications with no changes	Tenofovir n=14 Participants Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24	-0.2 ml/mmHg x10 Interval -1.7 to 3.1	-0.4 ml/mmHg x10 Interval -1.9 to 1.7

Adverse Events

Abacavir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tenofovir

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

Dr. Jason Baker

Minneapolis Medical Foundation

Phone: 612-873-2705

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place