TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada (TOTEM)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV 1 Infection
Eligibility 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
Sites / Locations
- Gilead Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
Truvada
Maintain Baseline Regimen
Delayed Truvada
All Truvada
Truvada once daily with continuation of the current NNRTI or PI at randomization
Maintain baseline regimen
Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)
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)