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
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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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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Measure Type Primary
Measure Title Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
Measure Description Small 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 small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.
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.
Small artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in small artery elasticity (mL/mmHg x100) 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  
Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24  
[units: ml/mmHg x100]
Median ( Inter-Quartile Range )
  0.2  
  ( -0.5 to 2.3 )  
  -1.3  
  ( -2.8 to 2.7 )  

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



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.


  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


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