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

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00960622
First received: August 17, 2009
Last updated: January 25, 2013
Last verified: September 2012
Results First Received: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: 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.
No text entered.

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  
Number of Participants  
[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
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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
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  More Information