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

Phase 4 Completed 92 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-09
Primary completion: 2007-07
Completion: 2008-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Truvada vs Maintain Baseline Regimen; p = 0.034; Median Difference (Net) -0.42 (95% CI -0.86 to -0.03); Wilcoxon Rank Sum test NCT00323492 ↗

registry analysis (superiority or other test); Truvada vs Maintain Baseline Regimen; p = 0.031; Median Difference (Net) -0.36 (95% CI -0.67 to -0.03); Wilcoxon Rank Sum text NCT00323492 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	—
Subject	emtricitabine	Other / unclassified	200 mg	—