TaISENWITCHA 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
Raltegravir switch
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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: The proportion of patients who are free of "virological failure" at week 48 after switch The change from baseline in CD4 cell counts at week 48 after switch 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. 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 The proportion of patients who are free of "treatment failure" at week 48 after switch Safety endpoints Incidence of adverse events The proportion of patients with treatment-related grade 3 or 4 adverse events and laboratory abnormalities
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.107 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, TaiwanChina Medical University Hospital
Taichung, TaiwanNational Cheng Kung University Hospital
Tainan, Taiwan