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

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.
 
ClinicalTrials.gov Identifier: NCT00323492
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : December 23, 2009
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE May 5, 2006
First Posted Date  ICMJE May 9, 2006
Results First Submitted Date  ICMJE March 20, 2009
Results First Posted Date  ICMJE December 23, 2009
Last Update Posted Date January 20, 2010
Study Start Date  ICMJE September 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2009)
  • Change From Baseline to Week 12 in Fasting Triglycerides [ Time Frame: Baseline to Week 12 ]
    Centralized laboratory assessment. Change = Week 12 value minus baseline value.
  • Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO) [ Time Frame: Baseline to Week 12 ]
    Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • Comparison of the evolution of the lipid profile between the two treatment groups, from baseline to Week 12, evaluated on:
  • Plasma triglycerides levels changes
  • Plasma direct measured LDL-CHO
  • The changes in HDL-CHO, and T CHO levels.
  • The changes in T-CHO/ HDL-CHO and HDL-CHO/LDL-CHO ratios.
  • The percentage of patients with plasma triglycerides greater than 10 g/L at Week 12
  • The percentage of patients with plasma HIV-1 viral load less than 400 copies /mL at Week 12 (virological control).
  • The percentage of patients with a plasma HIV-1 viral load greater than 400 copies/mL at Week 12 (virological therapy failure). The genotype of HIV 1 will be analyzed in case of failure.
  • The changes of cluster determinant 4 (CD4) cell counts from baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2009)
  • Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO) [ Time Frame: Baseline to Week 12 ]
    Centralized laboratory assessment. Change = Week 12 value minus baseline value.
  • Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO) [ Time Frame: Baseline to Week 12 ]
    Centralized laboratory assessment. Change = Week 12 value minus baseline value.
  • Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO [ Time Frame: Baseline to Week 12 ]
    Centralized laboratory assessment. Change = Week 12 value minus baseline value.
  • Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO [ Time Frame: Baseline to Week 12 ]
    Centralized laboratory assessment. Change = Week 12 value minus baseline value.
  • Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP) [ Time Frame: Baseline to Week 12 ]
    Local laboratory assessment. Change = Week 12 value minus baseline value.
  • Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12 [ Time Frame: 12 weeks ]
    Centralized laboratory assessment
  • Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count [ Time Frame: Baseline to Week 12 ]
    Change = Week 12 value minus baseline value.
  • Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline to Week 48 ]
    Change = Week 48 value minus baseline value.
  • Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12 [ Time Frame: 12 weeks ]
  • Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12 [ Time Frame: 12 weeks ]
  • Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
Official Title  ICMJE Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.
Brief Summary This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg [FTC/TDF]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.
Detailed Description

This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.

Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:

  • A. Truvada (substitution of their current NRTIs by Truvada [FTC/TDF] with continuation of their current NNRTI or PI at the same dose)
  • B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).

This phase of the study served the primary objective of the study.

Study Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).

Patients were assessed for efficacy and safety during both phases of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Truvada
    Truvada + NNRTI or PI.
  • Drug: Current HAART regimen
    Maintain baseline regimen
Study Arms  ICMJE
  • Experimental: Truvada
    Truvada once daily with continuation of the current NNRTI or PI at randomization
    Intervention: Drug: Truvada
  • Active Comparator: Maintain Baseline Regimen
    Maintain baseline regimen
    Intervention: Drug: Current HAART regimen
  • Experimental: Delayed Truvada
    Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)
    Intervention: Drug: Truvada
  • Experimental: All Truvada
    Truvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups)
    Intervention: Drug: Truvada
Publications * Valantin MA, Bittar R, de Truchis P, Bollens D, Slama L, Giral P, Bonnefont-Rousselot D, Pétour P, Aubron-Olivier C, Costagliola D, Katlama C; TOTEM trial group. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother. 2010 Mar;65(3):556-61. doi: 10.1093/jac/dkp462. Epub 2010 Jan 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2009)
92
Original Enrollment  ICMJE
 (submitted: May 5, 2006)
120
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients displaying abnormal fasted triglycerides (> 2 g/L [2.26 mmol/L] and less than or equal to 10 g/L [11.29 mmol/L]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; > 1.6 g/L [4.15 mmol/L])
  • Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load < 400 copies/mL for at least 6 months prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323492
Other Study ID Numbers  ICMJE GS-FR-164-0109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Camille Aubron-Olivier, Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Camille Aubron-Olivier Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP