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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Truvada + NNRTI or PI.
Maintain baseline regimen
Gilead Sciences
Paris, France
Change From Baseline to Week 12 in Fasting Triglycerides
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time frame: 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.
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO
Centralized laboratory assessment. Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)
Local laboratory assessment. Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
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Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12
Centralized laboratory assessment
Time frame: 12 weeks
Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count
Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
Change From Baseline to Week 48 in CD4 Cell Count
Change = Week 48 value minus baseline value.
Time frame: Baseline to Week 48
Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12
Time frame: 12 weeks
Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12
Time frame: 12 weeks
Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48
Time frame: 48 weeks