NCT01679964

Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study

A Single Arm Study to Assess the Sustained Virological Suppression and Improvement of Treatment-emerged Adverse Events of Switching to Raltegravir in Stable HIV-infected Patients on Ritonavir-boosted Protease Inhibitor Regimen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Lin, Hsi-Hsun, M.D. · Individual
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• HIV Infection
• Adverse Drug Reaction
• Quality of Life

Interventions

Type	Name	Description
DRUG	Raltegravir switch	Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-09-06
• Last updated: 2016-09-15

Locations

7 sites across 1 country: Taiwan