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

Primary Purpose

HIV Infection, Adverse Drug Reaction, Quality of Life

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Raltegravir switch
Sponsored by
Lin, Hsi-Hsun, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, Raltegravir, Adverse event, Life quality

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are infected with HIV-1
  • Ages at least 20 years
  • Patients are currently receiving a ritonavir-boosted PI-based regimen, including lopinavir, atazanavir, or darunavir, plus at least 2 antiretroviral agents (NRTIs)
  • Patient complained of treatment-emerged clinical adverse events or abnormal lipid profile
  • Patients with plasma HIV-1 viral RNA below 50 copies per ml for at least 6 months

Exclusion Criteria:

  • Patient with known history of contraindication or hypersensitivity to any component of the study regimen
  • Patients with acute or decompensated chronic hepatitis in the previous 6 months
  • Patients with chronic hepatitis and serum aminotransferase concentrations are more than 5 times the upper limit of the normal range
  • Patients with renal insufficiency (patients need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
  • Current alcohol or substance abuse (patients receiving methadone for the management of withdrawal symptoms due to substance abuse are allowed )
  • Patients have failed previous regimens (prior to starting the current 2NRTI+PI/r regimen they are currently on)
  • Patient's viral load have not been consistently <50 copies per ml for 6 months or longer.
  • Patients initiated lipid lowering agents during the preceding 3 months
  • Patients with any medical disorder or history of any illness which, in the opinion of the investigator, that the use of study medications is contraindicated or might confound the results of the study or pose additional risk in administering study drugs to the patient
  • Pregnant, wish to become pregnant during the study period or breastfeeding women
  • Patients who are lack of expectation to maintain assigned study medication during study period
  • Patients who have received therapy with investigational drugs in the previous 3 months

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • E-Da Hospital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei City Hospital
  • Chang Gung Memorial Hospital at Linkou

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Raltegravir switch

Arm Description

Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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
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

Full Information

First Posted
August 30, 2012
Last Updated
September 14, 2016
Sponsor
Lin, Hsi-Hsun, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01679964
Brief Title
Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study
Acronym
TaISENWITCH
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lin, Hsi-Hsun, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Adverse Drug Reaction, Quality of Life
Keywords
HIV infection, Raltegravir, Adverse event, Life quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir switch
Arm Type
Other
Arm Description
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
Intervention Type
Drug
Intervention Name(s)
Raltegravir switch
Other Intervention Name(s)
Isentress
Intervention Description
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
Primary Outcome Measure Information:
Title
The proportion of patient-reported clinical adverse events
Description
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
Secondary Outcome Measure Information:
Title
The proportion of patients who are free of "virological failure"
Description
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
Title
The change from baseline in CD4 cell counts
Description
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
Title
the change from baseline in life quality (based on the MOS-HIV questionnaire)
Description
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
Title
The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides)
Description
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
Title
The proportion of patients with treatment failure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are infected with HIV-1 Ages at least 20 years Patients are currently receiving a ritonavir-boosted PI-based regimen, including lopinavir, atazanavir, or darunavir, plus at least 2 antiretroviral agents (NRTIs) Patient complained of treatment-emerged clinical adverse events or abnormal lipid profile Patients with plasma HIV-1 viral RNA below 50 copies per ml for at least 6 months Exclusion Criteria: Patient with known history of contraindication or hypersensitivity to any component of the study regimen Patients with acute or decompensated chronic hepatitis in the previous 6 months Patients with chronic hepatitis and serum aminotransferase concentrations are more than 5 times the upper limit of the normal range Patients with renal insufficiency (patients need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range Current alcohol or substance abuse (patients receiving methadone for the management of withdrawal symptoms due to substance abuse are allowed ) Patients have failed previous regimens (prior to starting the current 2NRTI+PI/r regimen they are currently on) Patient's viral load have not been consistently <50 copies per ml for 6 months or longer. Patients initiated lipid lowering agents during the preceding 3 months Patients with any medical disorder or history of any illness which, in the opinion of the investigator, that the use of study medications is contraindicated or might confound the results of the study or pose additional risk in administering study drugs to the patient Pregnant, wish to become pregnant during the study period or breastfeeding women Patients who are lack of expectation to maintain assigned study medication during study period Patients who have received therapy with investigational drugs in the previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsi-Hsun Lin, MD
Organizational Affiliation
E-DA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
E-Da Hospital
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
108
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Walensky RP. The survival benefits of AIDS treatment in the US. J Infect Dis 2006;194:11-19 Lennox JL. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection. Lancet 2009;374:796-806 Steigbigel RT. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection. Clin Infect Dis 2010;50:605-12 Eron JJ. Switch to raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2). Lancet 2010;375:396-407 Martinex E. Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS 2010, 24:1697-1707 Division of AIDS(DAIDS). Toxicity guideline for adults. http://rcc.tech-res.com/safetyand pharmacovigilance(accessed Apr 15, 2011)
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Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study

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