HIV Infections Clinical Trial
Official title:
Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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