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Artery Elasticity After Switch From Epzicom to Truvada

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ClinicalTrials.gov Identifier: NCT00998582
Recruitment Status : Terminated (Low enrollment)
First Posted : October 20, 2009
Results First Posted : March 23, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):

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

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

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 
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

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

Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Abacavir   Tenofovir
Total, Serious Adverse Events     
# participants affected / at risk   0/13 (0.00%)   0/14 (0.00%) 




  Other Adverse Events


  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.


  More Information