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

May 5, 2006
January 13, 2010
September 2005
July 2007   (final data collection date for primary outcome measure)
  • Change From Baseline to Week 12 in Fasting Triglycerides [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • The changes of cluster determinant 4 (CD4) cell counts from baseline
  • Plasma direct measured LDL-CHO
  • Comparison of the evolution of the lipid profile between the two treatment groups, from baseline to Week 12, evaluated on:
  • 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.
  • Plasma triglycerides levels changes
Complete list of historical versions of study NCT00323492 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Truvada
    Truvada + NNRTI or PI.
  • Drug: Current HAART regimen
    Maintain baseline regimen
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
March 2008
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00323492
GS-FR-164-0109
No
Camille Aubron-Olivier, Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Camille Aubron-Olivier Gilead Sciences
Gilead Sciences
January 2010

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