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Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects (TRU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960622
First Posted: August 18, 2009
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
Results First Submitted: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Truvada
Drug: Combivir
Drug: Trizivir

  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
  Description
Truvada switch from Combivir to Truvada
Combivir, Trizivir. continue on Combivir, trizivir.
Total Total of all reporting groups

Baseline Measures
   Truvada   Combivir, Trizivir.   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (6)   53  (4)   53  (7) 
Gender 
[Units: Participants]
     
Female   1   1   2 
Male   9   9   18 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Change in Peak Oxygen Uptake.   [ Time Frame: baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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  More Information