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

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. Identifier: NCT00960622
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Gilead Sciences
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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

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
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 

  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
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 52  (6)   53  (4)   53  (7) 
[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

  More Information