Artery Elasticity After Switch From Epzicom to Truvada

This study has been terminated.
(Low enrollment)
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation Identifier:
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

  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
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  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     13     14     27  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  47  (7)     43  (9)     46  (8)  
[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 ]

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 ]

  Serious Adverse Events

  Other Adverse Events

  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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