Full Text View
Tabular View
No Study Results Posted
Related Studies
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
This study has been completed.
Study NCT00323492   Information provided by Gilead Sciences
First Received: May 5, 2006   Last Updated: November 12, 2008   History of Changes

May 5, 2006
November 12, 2008
April 2005
April 2008   (final data collection date for primary outcome measure)
  • Comparison of the evolution of the lipid profile between the two treatment groups, from baseline to Week 12, evaluated on: Plasma triglyceride level changes [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • Plasma direct measured low-density lipoprotein cholesterol (LDL-CHO) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • The changes in high-density lipoprotein cholesterol (HDL-CHO), and total cholesterol (T-CHO) levels [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • The changes in T-CHO/ HDL-CHO and HDL-CHO/LDL-CHO ratios [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • The percentage of patients with plasma triglycerides greater than 10 g/L at Week 12 [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • The percentage of patients with plasma HIV-1 viral load less than 400 copies/mL at Week 12 (virological control) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Through 12 weeks ] [ Designated as safety issue: No ]
  • The changes of cluster determinant 4 (CD4) cell counts from baseline [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
  • Comparison of the evolution of the lipid profile between the two treatment groups, from baseline to Week 12, evaluated on:
  • 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
  • Plasma triglycerides levels changes
Complete list of historical versions of study NCT00323492 on ClinicalTrials.gov Archive Site
 
 
 
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
Pilot Open-Label Randomized Multicentre Trial to Evaluate the Impact of the Substitution of the NRTIs With TRUVADA in a HAART Combination Over the Lipids Profile in HIV+ Infected Patients

This study looks at lipid changes in HIV infected patients when they are switched from existing HIV treatment to a treatment containing Truvada.

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

Phase 1, Day-14 to Week12: patients will be, on a 1:1 basis, randomized to two arms: A. the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose) or B. a control group (continuation of previous HAART regimen). This phase of the study serves the Primary objective of the study.

Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.

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

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
HIV Infections
  • Drug: Truvada
  • Drug: Current HAART regimen
  • Experimental: Phase 1, Day-14 to Week12:the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose)
  • Active Comparator: Phase 1, Day-14 to Week12: a control group (continuation of previous HAART regimen)
  • Experimental: Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
August 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients displaying abnormal plasma lipid levels
  • Patients with stable highly active antiretroviral therapy (HAART)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00323492
Camille Aubron-Olivier, Gilead Sciences
GS-FR-164-0109
Gilead Sciences
 
Study Director: Camille Aubron-Olivier Gilead Sciences
Gilead Sciences
November 2008

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