Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study (TaISENWITCH)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Lin, Hsi-Hsun, M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Lin, Hsi-Hsun, M.D.
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Adverse Drug Reaction Quality of Life |
Drug: Raltegravir switch |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Lin, Hsi-Hsun, M.D.:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Raltegravir switch
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)
Other Name: Isentress
|
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:
- The changes in overall incidence and severity of patient-reported clinical adverse events (based on "symptom distress module) after switch to raltegravir-based therapy.
- 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
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.
Safety endpoints
- Incidence of adverse events
- The proportion of patients with treatment-related grade 3 or 4 adverse events and laboratory abnormalities
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679964
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679964
Contacts
| Contact: Hsi-Hsun Lin, MD | +886-76150011 ext 5550 | ed100233@yahoo.com.tw |
Locations
| Taiwan | |
| E-Da Hospital | Recruiting |
| Kaohsiung, Taiwan, 824 | |
| Contact: Hsi-Hsun Lin, MD +886-7-615-0011 ext 5550 ed100233@yahoo.com.tw | |
| Principal Investigator: Hsi-Hsun Lin, MD | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Not yet recruiting |
| Kaohsiung, Taiwan, 807 | |
| Contact: Tun-Chieh Chen, M.D. +886-7-2911101 ext 8960 kmtthidchen@gmail.com | |
| Principal Investigator: Tun-Chieh Chen, M.D. | |
| China Medical University Hospital | Not yet recruiting |
| Taichung, Taiwan, 40447 | |
| Contact: Mao-Wang Ho, M.D. +886-4-22076681 cmchid@yahoo.com.tw | |
| Principal Investigator: Mao-Wang Ho, M.D. | |
| National Cheng Kung University Hospital | Not yet recruiting |
| Tainan, Taiwan, 704 | |
| Contact: Wen-Chien Ko, M.D. +886-6-2353535 ext 3596 winston3415@gmail.com | |
| Principal Investigator: Wen-Chien Ko, M.D. | |
| National Taiwan University Hospital | Not yet recruiting |
| Taipei, Taiwan, 10048 | |
| Contact: Szu-Min Hsieh, M.D. +886-2-23123456 ext 66842 hsmaids@hotmail.com | |
| Principal Investigator: Szu-Min Hsieh, M.D. | |
| Taipei City Hospital | Not yet recruiting |
| Taipei, Taiwan, 108 | |
| Contact: Bor-Shen Hu, M.D. +886-2-23889595 ext 2801 DAD85@tpech.gov.tw | |
| Principal Investigator: Bor-Shen Hu, M.D. | |
| Chang Gung Memorial Hospital at Linkou | Not yet recruiting |
| Taoyuan, Taiwan, 333 | |
| Contact: Ching-Tai Huang, M.D. +886-3-3281200 ext 8450 chingtaihuang@gmail.com | |
| Principal Investigator: Ching-Tai Huang, M.D. | |
Sponsors and Collaborators
Lin, Hsi-Hsun, M.D.
Investigators
| Principal Investigator: | Hsi-Hsun Lin, MD | E-DA Hospital |
More Information
No publications provided
| Responsible Party: | Lin, Hsi-Hsun, M.D. |
| ClinicalTrials.gov Identifier: | NCT01679964 History of Changes |
| Other Study ID Numbers: | MISP40301, MISP 40301 |
| Study First Received: | August 30, 2012 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Lin, Hsi-Hsun, M.D.:
|
HIV infection Raltegravir Adverse event Life quality |
Additional relevant MeSH terms:
|
HIV Protease Inhibitors Protease Inhibitors Reverse Transcriptase Inhibitors Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents |
Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015