Artery Elasticity After Switch From Epzicom to Truvada

This study has been terminated.

(Low enrollment)

Sponsor:

Information provided by (Responsible Party):

Minneapolis Medical Research Foundation

ClinicalTrials.gov Identifier:

NCT00998582

First received: October 19, 2009

Last updated: October 3, 2012

Last verified: October 2012

History of Changes

Results First Received: January 16, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Intervention:	Drug: Tenofovir disoproxil

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow: Overall Study

	Abacavir	Tenofovir
STARTED	13	14
COMPLETED	13	14
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	Abacavir	Tenofovir	Total
Number of Participants [units: participants]	13	14	27
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	13	14	27
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	47 ± 7	43 ± 9	46 ± 8
Gender [units: participants]
Female	1	0	1
Male	12	14	26
Region of Enrollment [units: participants]
United States	13	14	27

Outcome Measures

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1. Primary:

Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 [ Time Frame: Change from baseline to 24 weeks ]

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2. Primary:

Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 [ Time Frame: Change from baseline to 24 weeks ]

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Measure Type	Primary
Measure Title	Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
Measure Description	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.
Time Frame	Change from baseline to 24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups

	Description
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

Measured Values

	Abacavir	Tenofovir
Number of Participants Analyzed [units: participants]	13	14
Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 [units: ml/mmHg x10] Median ( Inter-Quartile Range )	-0.2 ( -1.7 to 3.1 )	-0.4 ( -1.9 to 1.7 )

No statistical analysis provided for Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study stopped early due to low/inadequate enrollment and findings are subsequently limited by low power to detect differences.

Results Point of Contact:

Name/Title: Dr. Jason Baker
Organization: Minneapolis Medical Foundation
phone: 612-873-2705
e-mail: baker459@umn.edu

No publications provided

Responsible Party:	Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00998582 History of Changes
Other Study ID Numbers:	PCC-004
Study First Received:	October 19, 2009
Results First Received:	January 16, 2012
Last Updated:	October 3, 2012
Health Authority:	United States: Institutional Review Board

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