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

Condition(s) targeted: HIV Infections

Intervention: Truvada (Drug); Current HAART regimen (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Camille Aubron-Olivier, Study Director, Affiliation: Gilead Sciences

This study looks at lipid changes in HIV infected patients when they are switched from existing HIV treatment to a treatment containing Truvada.

Official title: Pilot Open-Label Randomized Multicentre Trial to Evaluate the Impact of the Substitution of the NRTIs With TRUVADA in a HAART Combination Over the Lipids Profile in HIV+ Infected Patients

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome:

Comparison of the evolution of the lipid profile between the two treatment groups, from baseline to Week 12, evaluated on: Plasma triglyceride level changes

Plasma direct measured low-density lipoprotein cholesterol (LDL-CHO)

The changes in high-density lipoprotein cholesterol (HDL-CHO), and total cholesterol (T-CHO) levels

The changes in T-CHO/ HDL-CHO and HDL-CHO/LDL-CHO ratios

The percentage of patients with plasma triglycerides greater than 10 g/L at Week 12

The percentage of patients with plasma HIV-1 viral load less than 400 copies/mL at Week 12 (virological control)

The percentage of patients with a plasma HIV-1 viral load greater than 400 copies/mL at Week 12 (virological therapy failure). The genotype of HIV-1 will be analyzed in case of failure

The changes of cluster determinant 4 (CD4) cell counts from baseline

Detailed description: This is a Phase IV, multicenter (in France) and open label study. The study is conducted in two phases, a comparative randomized phase, which serves the primary objective of the study, and a follow up phase.

Phase 1, Day-14 to Week12: patients will be, on a 1: 1 basis, randomized to two arms: A. the TVD group (substitution of their current NRTIs by TVD [TDF+FTC] with continuation of their current NNRTI or PI at the same dose) or B. a control group (continuation of previous HAART regimen). This phase of the study serves the Primary objective of the study.

Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the TVD group (Arm A) continue with TVD + an NNRTI or PI. Patients who did not switch in Phase 1 to TVD (Arm B) will be proposed to switch in this phase of the study.

Patients will be assessed for efficacy and safety during both phases of the study.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients displaying abnormal plasma lipid levels

- Patients with stable highly active antiretroviral therapy (HAART)

Gilead Sciences, Paris 75015, France

Starting date: April 2005
Ending date: August 2008
Last updated: April 25, 2008