Artery Elasticity After Switch From Epzicom to Truvada

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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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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.
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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
Overall Participants Analyzed; [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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  Serious Adverse Events

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  Limitations and Caveats

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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.

  More Information

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Certain Agreements:  

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

Results Point of Contact:  

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

Responsible Party:	Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00998582 History of Changes
Other Study ID Numbers:	PCC-004
First Submitted:	October 19, 2009
First Posted:	October 20, 2009
Results First Submitted:	January 16, 2012
Results First Posted:	March 23, 2012
Last Update Posted:	October 8, 2012