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

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

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

Baseline Characteristics

Outcome Measures

1. Primary:

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

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

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