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

This study is currently recruiting participants.
Verified September 2012 by Lin, Hsi-Hsun, M.D.
Sponsor:
Information provided by (Responsible Party):
Lin, Hsi-Hsun, M.D.
ClinicalTrials.gov Identifier:
NCT01679964
First received: August 30, 2012
Last updated: September 5, 2012
Last verified: September 2012

August 30, 2012
September 5, 2012
July 2012
June 2014   (final data collection date for primary outcome measure)
  • The proportion of patient-reported clinical adverse events [ Time Frame: Week 4, 12-16, 28-32, 48 ] [ Designated as safety issue: Yes ]
    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
  • The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides) [ Time Frame: Week 4, 12-16, 28-32, 48 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 4, 12-16, 28-32, 48 ] [ Designated as safety issue: No ]
    The proportion of patients with treatment failure at 4 weeks, The proportion of patients with treatment failure at 12-16 weeks, The proportion of patients with treatment failure at 28-32 weeks, The proportion of patients with treatment failure at 48 weeks
Same as current
Complete list of historical versions of study NCT01679964 on ClinicalTrials.gov Archive Site
  • The proportion of patients who are free of "virological failure" [ Time Frame: Week 4, 12-16, 28-32, 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4, 12-16, 28-32, 48 ] [ Designated as safety issue: No ]
    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) [ Time Frame: week 12-16, 48 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

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:

  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.
  2. 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
  3. The proportion of patients who are free of "treatment failure" at week 48 after switch

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.

Safety endpoints

  1. Incidence of adverse events
  2. The proportion of patients with treatment-related grade 3 or 4 adverse events and laboratory abnormalities
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • Adverse Drug Reaction
  • Quality of Life
Drug: Raltegravir switch
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
Other Name: Isentress
Raltegravir switch
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
Intervention: Drug: Raltegravir switch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Hsi-Hsun Lin, MD +886-76150011 ext 5550 ed100233@yahoo.com.tw
Taiwan
 
NCT01679964
MISP40301, MISP 40301
No
Lin, Hsi-Hsun, M.D.
Lin, Hsi-Hsun, M.D.
Not Provided
Principal Investigator: Hsi-Hsun Lin, MD E-DA Hospital
Lin, Hsi-Hsun, M.D.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP