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

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Pre-Assignment Details

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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

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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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Serious Adverse Events

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Other Adverse Events

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Frequency Threshold

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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

Other Adverse Events

	Abacavir	Tenofovir
Total, other (not including serious) adverse events
# participants affected / at risk	0/13 (0.00%)	0/14 (0.00%)

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.

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