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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
  Hide Participant Flow

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


  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