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

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Truvada Drug: Current HAART regimen	Phase 4

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 Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Truvada

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


France
Gilead Sciences
Paris, France, 75015

Sponsors and Collaborators

Gilead Sciences

Investigators


Study Director:	Camille Aubron-Olivier	Gilead Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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

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