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

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ClinicalTrials.gov Identifier: NCT00960622
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Sponsor:
Collaborator:
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
Enrollment 17
Recruitment Details Subjects were recruited from clinics.
Pre-assignment Details Subjects had to take combivir or trizivir for at least 6 months prior to enrollment
Arm/Group Title Truvada 200/300 mg, Daily, by Mouth. Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.
Hide Arm/Group Description The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada. The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
Period Title: Overall Study
Started 10 10
Completed 10 7
Not Completed 0 3
Arm/Group Title Truvada Combivir, Trizivir. Total
Hide Arm/Group Description switch from Combivir to Truvada continue on Combivir, trizivir. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
52  (6) 53  (4) 53  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
1
  10.0%
1
  10.0%
2
  10.0%
Male
9
  90.0%
9
  90.0%
18
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Change in Peak Oxygen Uptake.
Hide Description change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Truvada 200/300 mg, Daily, by Mouth. Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.
Hide Arm/Group Description:
switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.
continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ml/Kg/min
2.2  (8.5) 2.8  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada 200/300 mg, Daily, by Mouth., Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.
Comments

Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.

P<0.05 chosen for statistical significance

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-6.3 to 11.3
Parameter Dispersion
Type: Standard Deviation
Value: 8.5
Estimation Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Truvada Combivir, Trizivir.
Hide Arm/Group Description switch from Combivir to Truvada continue on Combivir, trizivir.
All-Cause Mortality
Truvada Combivir, Trizivir.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Truvada Combivir, Trizivir.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Truvada Combivir, Trizivir.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Results Point of Contact
Name/Title: Dr. Donald Phillip Kotler
Organization: St Luke's Roosevelt Hospital New York
Phone: 212 523 3670
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00960622     History of Changes
Other Study ID Numbers: TRU
First Submitted: August 17, 2009
First Posted: August 18, 2009
Results First Submitted: September 21, 2011
Results First Posted: March 4, 2013
Last Update Posted: March 4, 2013