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
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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
Subjects were recruited from clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had to take combivir or trizivir for at least 6 months prior to enrollment

Reporting Groups
  Description
Truvada 200/300 mg, Daily, by Mouth. The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.

Participant Flow:   Overall Study
    Truvada 200/300 mg, Daily, by Mouth.     Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.  
STARTED     10     10  
COMPLETED     10     7  
NOT COMPLETED     0     3  



  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
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Time Frame 1 year
Additional Description No text entered.

Reporting Groups
  Description
Truvada switch from Combivir to Truvada
Combivir, Trizivir. continue on Combivir, trizivir.

Serious Adverse Events
    Truvada     Combivir, Trizivir.  
Total, serious adverse events      
# participants affected / at risk     0/10 (0.00%)     0/10 (0.00%)  




  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Donald Phillip Kotler
Organization: St Luke's Roosevelt Hospital New York
phone: 212 523 3670
e-mail: dkotler@chpnet.org


No publications provided


Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00960622     History of Changes
Other Study ID Numbers: TRU
Study First Received: August 17, 2009
Results First Received: September 21, 2011
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration