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Clinical Trial Summary

Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable HIV-infected adult patients receiving combination therapy will demonstrate improved clinical tolerability or lipid profiles with sustained plasma virological response (<50 copies/ml).


Clinical Trial Description

A. Objectives To compare the treatment-emerged AEs and virological suppression after switch to raltegravir-based therapy in stable HIV-infected patients who receiving ritonavir-boosted protease inhibitor antiretroviral regimen

Primary endpoints:

1) The changes in overall incidence and severity of patient-reported clinical adverse events (based on "symptom distress module) after switch to raltegravir-based therapy.

Secondary endpoints:

1. The proportion of patients who are free of "virological failure" at week 48 after switch

2. The change from baseline in CD4 cell counts at week 48 after switch

3. The change in quality of life by assess the changes in the domain scores of MOS-HIV questionnaire at baseline and different study time points.

4. The changes in laboratory adverse event, e.g., the mean percent changes from baseline to 48 weeks in plasma lipid profile (total cholesterol, LDLCholesterol, HDL Cholesterol, triglycerides) after switch

5. The proportion of patients who are free of "treatment failure" at week 48 after switch

Safety endpoints

1. Incidence of adverse events

2. The proportion of patients with treatment-related grade 3 or 4 adverse events and laboratory abnormalities ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01679964
Study type Interventional
Source Lin, Hsi-Hsun, M.D.
Contact
Status Completed
Phase Phase 4
Start date July 2012
Completion date February 2015

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