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

NCT00323492 | Completed Phase 4 Results

• 1 other identifier: GS-FR-164-0109
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV 1 Infection

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 12 in Fasting Triglycerides

  Centralized laboratory assessment. Change = Week 12 value minus baseline value.

  Baseline to Week 12

• Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)

  Centralized laboratory assessment. Change = Week 12 value minus baseline value.

  Baseline to Week 12

Secondary Outcomes (11)

• Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)

  Baseline to Week 12

• Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)

  Baseline to Week 12

• Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO

  Baseline to Week 12

• Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO

  Baseline to Week 12

• Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)

  Baseline to Week 12

Study Arms (4)

Truvada

EXPERIMENTAL

Truvada once daily with continuation of the current NNRTI or PI at randomization

Drug: Truvada

Maintain Baseline Regimen

ACTIVE COMPARATOR

Maintain baseline regimen

Drug: Current HAART regimen

Delayed Truvada

EXPERIMENTAL

Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)

Drug: Truvada

All Truvada

EXPERIMENTAL

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

Interventions

Truvada DRUG

Truvada + NNRTI or PI.

All Truvada; Delayed Truvada; Truvada

Current HAART regimen DRUG

Maintain baseline regimen

Maintain Baseline Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences

Paris, 75015, France

Location

Related Publications (1)

• Valantin MA, Bittar R, de Truchis P, Bollens D, Slama L, Giral P, Bonnefont-Rousselot D, Petour 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.

  PMID: 20053692 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Comparison of adverse events between Truvada and maintain baseline regimen groups is inappropriate since numbers at risk (and exposure to study drug) are not balanced, as described in the adverse event treatment group descriptions.

Results Point of Contact

• Title: Camille Aubron-Olivier
• Organization: Gilead Sciences

camille.aubron-olivier@gilead.com

+33(0)1 42 737130

Study Officials

• Camille Aubron-Olivier

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: September 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: March 1, 2008
• Last Updated: January 20, 2010
• Results First Posted: December 23, 2009

Record last verified: 2010-01

Locations

FR (1)