At a glance
ClinicalIndex Comparison Record- ✓Abnormal fasted triglycerides (>2 g/L and ≤10 g/L) and/or fasted LDL cholesterol (>1.6 g/L)
- ✓On stable HAART regimen with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months before screening
- ✓Plasma viral load <400 copies/mL for at least 6 months before screening
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 4 clinical trial evaluating Truvada and Current HAART regimen for HIV Infections. Completed, enrolled 92 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Truvada + NNRTI or PI.
Maintain baseline regimen