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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Truvada Drug: Current HAART regimen | Phase 4 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Truvada
Truvada once daily with continuation of the current NNRTI or PI at randomization
|
Drug: Truvada
Truvada + NNRTI or PI.
|
Active Comparator: Maintain Baseline Regimen
Maintain baseline regimen
|
Drug: Current HAART regimen
Maintain baseline regimen
|
Experimental: Delayed Truvada
Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)
|
Drug: Truvada
Truvada + NNRTI or PI.
|
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)
|
Drug: Truvada
Truvada + NNRTI or PI.
|
- Change From Baseline to Week 12 in Fasting Triglycerides [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO) [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO) [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO) [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP) [ Time Frame: Baseline to Week 12 ]
- Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12 [ Time Frame: 12 weeks ]
- Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count [ Time Frame: Baseline to Week 12 ]
- Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline to Week 48 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323492
France | |
Gilead Sciences | |
Paris, France, 75015 |
Study Director: | Camille Aubron-Olivier | Gilead Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Camille Aubron-Olivier, Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00323492 History of Changes |
Other Study ID Numbers: |
GS-FR-164-0109 |
First Posted: | May 9, 2006 Key Record Dates |
Results First Posted: | December 23, 2009 |
Last Update Posted: | January 20, 2010 |
Last Verified: | January 2010 |
Keywords provided by Gilead Sciences:
HIV 1 Infection |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |