HIV InfectionPhase 4TaISENWITCHNCT01679964
Sustained Virological Suppression and Improvement of Adverse Events of Switching to Raltegravir Study
A Phase 4 study testing Raltegravir switch in people with HIV Infection and Adverse Drug Reaction, run by Lin, Hsi-Hsun, M.D. at 7 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV Infection, Adverse Drug Reaction, Quality of Life
- What is being tested?
- Raltegravir switch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 7 sitesTaiwan
- Study dates
- Jul 2012to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
E-Da Hospital
Kaohsiung, Taiwan, 824
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10048
Taipei City Hospital
Taipei, 108
Chang Gung Memorial Hospital at Linkou
Taoyuan, 333
About this study
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
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).
Read the detailed description
- 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.
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
- Conditions
- HIV Infection, Adverse Drug Reaction, Quality of Life
- Being tested
- Raltegravir switch
- Keywords
- HIV infection, Raltegravir, Adverse event, Life quality
- Medical subject headings
- HIV Infections, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir switchDrug
Also called Isentress
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir switch | Other | Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors) Receives: Drug: Raltegravir switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 4, 12-16, 28-32, 48
Secondary outcomes (5)
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
Measured: Week 4, 12-16, 28-32, 48
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
Measured: Week 4, 12-16, 28-32, 48
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.
Measured: week 12-16, 48
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
Measured: Week 4, 12-16, 28-32, 48
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
Measured: Week 4, 12-16, 28-32, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lin, Hsi-Hsun, M.D.
- Responsible party
- Sponsor
- Investigators
- Hsi-Hsun Lin, MD, Principal investigator, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679964
- Sponsor's protocol ID
- MISP40301
- Other IDs
- MISP 40301
- Acronym
- TaISENWITCH
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2012
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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)
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01679964
- Acronym / sponsor ID
- TaISENWITCH / MISP40301
- Conditions
- HIV Infection, Adverse Drug Reaction, Quality of Life
- Keywords
- HIV infection, Raltegravir, Adverse event, Life quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Lin, Hsi-Hsun, M.D.
- Study start
- Jul 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir switch | Other | Drug: Raltegravir switchIsentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raltegravir switchAlso: IsentressIsentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors) | Drug | Raltegravir switch |
Primary outcome
The proportion of patient-reported clinical adverse events
Time frame: Week 4, 12-16, 28-32, 48
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
5 secondary outcomes
The proportion of patients who are free of "virological failure"
Time frame: Week 4, 12-16, 28-32, 48
The change from baseline in CD4 cell counts
Time frame: Week 4, 12-16, 28-32, 48
the change from baseline in life quality (based on the MOS-HIV questionnaire)
Time frame: week 12-16, 48
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
The proportion of patients with treatment failure
Time frame: Week 4, 12-16, 28-32, 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- BackgroundWalensky 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)
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsi-Hsun Lin, MD principal investigator
E-DA Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir switch in people with HIV Infection and Adverse Drug Reaction, run by Lin, Hsi-Hsun, M.D. at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patient-reported clinical adverse events (time frame: Week 4, 12-16, 28-32, 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01679964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.