A Phase 4 interventional study of Raltegravir switch in HIV Infection, Adverse Drug Reaction and Quality of Life, sponsored by Lin, Hsi-Hsun, M.D.. Completed at 7 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-09-15.
Sponsored by Lin, Hsi-Hsun, M.D. · Phase 4, Interventional, and Treatment
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).
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:
Secondary endpoints:
Safety endpoints
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 107 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →This is the only study on the registry with Lin, Hsi-Hsun, M.D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
Drug: Raltegravir switch
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
Also known as: Isentress
The proportion of patient-reported clinical adverse events
The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 4 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 12-16 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 28-32 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 48 weeks
Time frame: Week 4, 12-16, 28-32, 48
The proportion of patients who are free of "virological failure"
The proportion of patients who are free of "virological failure" at week 4 after switch, The proportion of patients who are free of "virological failure" at week 12-16 after switch, The proportion of patients who are free of "virological failure" at week 28-32 after switch, The proportion of patients who are free of "virological failure" at week 48 after switch
Time frame: Week 4, 12-16, 28-32, 48
The change from baseline in CD4 cell counts
The change from baseline in CD4 cell counts at week 4 after switch, The change from baseline in CD4 cell counts at week 12-16 after switch, The change from baseline in CD4 cell counts at week 28-32 after switch, The change from baseline in CD4 cell counts at week 48 after switch
Time frame: Week 4, 12-16, 28-32, 48
the change from baseline in life quality (based on the MOS-HIV questionnaire)
The change from baseline in quality of life (based on the MOS-HIV questionnaire) at week 12-16 after switch, The change from baseline in quality of life (based on the MOS-HIV questionnaire) at week 48 after switch.
Time frame: week 12-16, 48
The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides)
The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 4 weeks, The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 12-16 weeks, The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 28-32 weeks, The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 48 weeks
Time frame: Week 4, 12-16, 28-32, 48
The proportion of patients with treatment failure
The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 4 weeks, The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 12-16 weeks, The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 28-32 weeks, The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) at 48 weeks
Time frame: Week 4, 12-16, 28-32, 48
Plan to share: No
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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