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

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00323492

Purpose

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	Intervention	Phase
HIV Infections	Drug: Truvada Drug: Current HAART regimen	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cholesterol HIV/AIDS

Drug Information available for: Benzocaine BaseLine Truvada

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	92
Study Start Date:	September 2005
Study Completion Date:	March 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323492

Locations

France
Gilead Sciences
Paris, France, 75015

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Camille Aubron-Olivier

Gilead Sciences

More Information

No publications provided

Responsible Party:	Camille Aubron-Olivier, Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00323492 History of Changes
Other Study ID Numbers:	GS-FR-164-0109
Study First Received:	May 5, 2006
Results First Received:	March 20, 2009
Last Updated:	January 13, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Gilead Sciences:

HIV 1 Infection

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012