TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00323492
First received: May 5, 2006
Last updated: January 13, 2010
Last verified: January 2010
Results First Received: March 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Truvada
Drug: Current HAART regimen

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Truvada Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
Maintain Baseline Regimen Maintain baseline regimen.
Delayed Truvada Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).

Participant Flow for 2 periods

Period 1:   Study Phase 1
    Truvada     Maintain Baseline Regimen     Delayed Truvada  
STARTED     47     45     0 [1]
Intent-to-Treat (ITT) Analysis Set     46 [2]   45     0  
COMPLETED     45     45     0  
NOT COMPLETED     2     0     0  
Adverse Event                 2                 0                 0  
[1] Not applicable to Phase 1.
[2] One subject was excluded from ITT analysis set due to protocol violation.

Period 2:   Study Phase 2
    Truvada     Maintain Baseline Regimen     Delayed Truvada  
STARTED     44 [1]   18 [2]   25 [3]
COMPLETED     40     17     24  
NOT COMPLETED     4     1     1  
Adverse Event                 1                 0                 0  
Physician Decision                 1                 0                 0  
Lost to Follow-up                 1                 0                 0  
Withdrawal by Subject                 0                 1                 0  
Noncompliance with study schedule                 0                 0                 1  
Protocol Violation                 1                 0                 0  
[1] 1/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=46
[2] 2/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=20 (no switch to Truvada)
[3] N=25 switched to Truvada in Phase 2.



  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 Truvada + NNRTI or PI.
Maintain Baseline Regimen Maintain baseline regimen.
Total Total of all reporting groups

Baseline Measures
    Truvada     Maintain Baseline Regimen     Total  
Number of Participants  
[units: participants]
  47     45     92  
Age  
[units: years]
Median ( Inter-Quartile Range )
  49.0  
  ( 42.0 to 58.0 )  
  43.0  
  ( 39.0 to 50.0 )  
  47.0  
  ( 41.0 to 55.0 )  
Gender  
[units: participants]
     
Female     8     4     12  
Male     39     41     80  
Region of Enrollment  
[units: participants]
     
France     47     45     92  
Participants with plasma HIV-1 RNA < 400 copies/mL [1]
[units: participants]
  47     45     92  
Cluster determinant 4 (CD4) cell count [1]
[units: cells/mm^3]
Median ( Inter-Quartile Range )
  467  
  ( 314 to 698 )  
  559  
  ( 337 to 714 )  
  528  
  ( 318 to 709 )  
Low density lipoprotein cholesterol (LDL-CHO) [2]
[units: mmol/L]
Median ( Inter-Quartile Range )
  4.0  
  ( 3.2 to 4.7 )  
  4.0  
  ( 3.6 to 4.8 )  
  4.0  
  ( 3.4 to 4.7 )  
Triglycerides [2]
[units: mmol/L]
Median ( Inter-Quartile Range )
  2.3  
  ( 1.9 to 4.0 )  
  2.7  
  ( 1.9 to 3.6 )  
  2.4  
  ( 1.9 to 3.7 )  
[1] At screening
[2] Centralized laboratory assessment



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 12 in Fasting Triglycerides   [ Time Frame: Baseline to Week 12 ]

2.  Primary:   Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:   Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)   [ Time Frame: Baseline to Week 12 ]

4.  Secondary:   Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)   [ Time Frame: Baseline to Week 12 ]

5.  Secondary:   Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO   [ Time Frame: Baseline to Week 12 ]

6.  Secondary:   Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO   [ Time Frame: Baseline to Week 12 ]

7.  Secondary:   Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)   [ Time Frame: Baseline to Week 12 ]

8.  Secondary:   Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12   [ Time Frame: 12 weeks ]

9.  Secondary:   Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count   [ Time Frame: Baseline to Week 12 ]

10.  Secondary:   Change From Baseline to Week 48 in CD4 Cell Count   [ Time Frame: Baseline to Week 48 ]

11.  Secondary:   Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12   [ Time Frame: 12 weeks ]

12.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12   [ Time Frame: 12 weeks ]

13.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48   [ Time Frame: 48 weeks ]


  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
Comparison of adverse events between Truvada and maintain baseline regimen groups is inappropriate since numbers at risk (and exposure to study drug) are not balanced, as described in the adverse event treatment group descriptions.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Camille Aubron-Olivier
Organization: Gilead Sciences
phone: +33(0)1 42 737130
e-mail: camille.aubron-olivier@gilead.com


No publications provided


Responsible Party: Camille Aubron-Olivier, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00323492     History of Changes
Other Study ID Numbers: GS-FR-164-0109
Study First Received: May 5, 2006
Results First Received: March 20, 2009
Last Updated: January 13, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)