Human Immunodeficiency Virus (HIV)POISENCT01615601
An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients
An observational study of Human Immunodeficiency Virus (HIV), run by Janssen Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are naïve to these medications and in patients who have experienced tolerability issues on their current or prior combination antiretroviral… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- darunavir (PREZISTA), etravirine (INTELENCE) and ritonavir
- Type of treatment
- Pill or oral medicine
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Apr 2013
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients infected with human immunodeficiency virus type 1 who have experienced tolerability issues on their current or prior ccombination antiretroviral therapy regimen and for whom a regimen including darunavir and/or etravirine is clinically indicated.
Who may be able to join
- Have a documented HIV-1 infection
- Have 1 or more significant symptoms with at least grade 2 toxicity on the Division of AIDS Toxicity "DAIDS grading scale" on current or prior combination antiretroviral therapy (cART) regimen (current or prior cART including regimens consisting of 2 Nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent with the exception of darunavir or etravirine)
- Have stable response to current cART ie, have an HIV-plasma viral load [number of virus in blood] at screening <400 copies/mL (undetectable) or last plasma viral load on prior regimen within the previous 6 months <400 copies/mL)
- Must not have resistance to Primary HIV protease inhibitor medicines
Who cannot join
- Has been Infected with HIV-2 - Has received previous treatment with darunavir or etravirine or non-HAART (Highly Active Antiretroviral Therapy) regimen
- Has had prior virologic failure to 2 or more regimens or single virologic failure on prior cART
- Has a documented resistance to darunavir and etravirine
- Is currently using any drug contraindicated in the current Canadian Product Monograph for darunavir or etravirine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREZISTA or INTELENCE Switch Evaluation in Virologically Suppressed Patients Naïve to Darunavir or Etravirine and Who Are Intolerant of Their Current or Prior Combination Antiretroviral Therapy Regimen: A Phase IV, Open-label, Multicentre Observational Trial
The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are naïve to these medications and in patients who have experienced tolerability issues on their current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by switching the patients from their previous or current combination antiretroviral therapy (cART) to either darunavir or etravirine.
Read the detailed description
This is an open label (all people know the identity of the intervention.), multicenter (study conducted at multiple sites), observational study (individuals are observed for certain outcomes) of darunavir and etravirine in patients infected with HIV-1 who are naïve to these medications and who have experienced tolerability issues on their current or prior combination antiretroviral therapy (medicines used for treatment of HIV). PREZISTA is indicated for naïve HIV patients (someone who has never used HIV drugs) and treatment-experienced HIV patients and INTELENCE is indicated for treatment-experienced patients who have failed prior therapy and have HIV-1 strains resistant to multiple antiretroviral agents (HIV-1 strains are able to survive the exposure of the multiple antiretroviral agents), including Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs). In this study patients will receive either darunavir (PREZISTA) or etravirine (INTELENCE) and physician selected optimized background agents (other antiretroviral medicines), as permitted by the local formulary and supported by the current Canadian Product Monograph. 90 patients will participate in this study (75 Patients planned for the darunavir group and 15 patients planned for the etravirine group). The total duration of the study will be 24 weeks. Safety and tolerability will be evaluated at screening (14 days prior to Day 1), baseline (patient's medical status before any treatment or research is done) at Day 1, Week 4, Week 12 and Week 24. Tolerability will be evaluated using HIV Symptom Distress Module (HIV-SDM) also referred to as the HIV Symptom Index (HSI) which is a self-completed questionnaire to evaluate symptoms and measure the presence and bothersomeness of side effects commonly seen with HIV and antiretroviral treatment over the last 4 weeks (20 questions about all symptoms which the patient might have had during the past four weeks). Higher scores indicate the presence of more symptoms and/or a greater degree of distress related to the 20 symptoms. In HIV-SDM data is collected to see the benefit of switching to either darunavir or etravirine.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- darunavir (PREZISTA), etravirine (INTELENCE), ritonavir, Other antiretroviral medications
- Keywords
- Human Immunodeficiency Virus, HIV, HIV-1, HIV type 1, Darunavir, PREZISTA, Etravirine, INTELENCE, HIV symptom Distress Module, HIV-SDM, Antiretroviral therapy, HIV Symptom Index (HSI),
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darunavir (PREZISTA)Drug
Form = tablet, route = oral, Units = mg, number = 800 administered once daily
etravirine (INTELENCE)Drug
Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily
ritonavirDrug
Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily
Other antiretroviral medicationsDrug
Given as per Canadian Product Monograph
| Study group | Role | What they receive |
|---|---|---|
| darunavir (PREZISTA) | PREZISTA co-administered with 100 mg ritonavir as per Canadian Product Monograph. (Observational Study) Receives: Drug: darunavir (PREZISTA); Drug: ritonavir | |
| etravirine (INTELENCE) | INTELENCE co-administered with other antiretroviral medicinal products as per Canadian Product Monograph (Observational Study) Receives: Drug: etravirine (INTELENCE); Drug: Other antiretroviral medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the patient's total score of the HIV Symptom Distress Module (HIV-SDM)
HIV-SDM is a questionnaire consisting of 20 questions related to all the symptoms which the patient might have had during the past four weeks. For each question patient has to select appropriate answer related to the symptoms: "0 = I do not have this symptom; 1 = I have this symptom and it doesn't bother me; 2 = it bothers me a little; 3 = it bothers me; 4 = it bothers me a lot". Total score of HIV-SDM is then calculated for all the 20 items.
Measured: Baseline (Day 1), Week 4, 12 and 24
Secondary outcomes (5)
Number of participants with Maintenance/achievement of virologic suppression at Week 24
Virologic suppression is decrease in the number of virus in blood. Number of participants with virologic suppression (who achieved virologic suppression) as well as the Number of participants who maintained virologic suppression will be summarized.
Measured: Baseline and Week 24
Number of participants with disappearance by Week 4 of at least one bothersome symptom identified at baseline by patient on HIV-SDM
The bothersome symptoms (defined as those reported as 'It bothers me a lot' or 'It bothers me') at baseline will be identified for each patient. The number of participants who report the disappearance of at least one of the bothersome symptoms (eg, reported as 'It bothers me a little', 'It does not bothers me', 'I do not have the symptom') by Week 4 will be summarized.
Measured: Baseline and Week 4
Number of participants with maintenance of disappearance by Week 12 and Week 24 of at least one bothersome symptom identified at baseline by patient on HIV-SDM
The number of participants who report the maintenance of the disappearance of at least one of the bothersome symptoms (eg, reported as It bothers me a little, 'It does not bothers me', 'I do not have the symptom') at Week 12 and Week 24 will be summarized.
Measured: Baseline, Week 12 and Week 24
Number of participants with Maintenance/increase in CD4 cell count.
CD4 cells (a type of white blood cells) are circulating in blood and gives an idea of how strong the HIV positive person's immune system really is. The values of CD4 cell counts will be summarized using mean, standard deviations, minimum and maximum at baseline and Week 24. In addition, the number of participants with maintenance or increase in CD4 cell counts will be summarized.
Measured: Baseline and Week 24
Comparison of change in HIV-SDM scores between those participants who were on or off ARTs at baseline
On and off ARTs is patients taking HIV medications and patients not taking HIV medications. The HIV-SDM change from baseline scores will be summarized using basic statistics (mean, standard deviations, minimum and maximum) by whether the patient is on or off ART at baseline.
Measured: Baseline, Week 4, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Inc. Clinical Trial, Study director, Janssen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615601
- Sponsor's protocol ID
- CR018595
- Other IDs
- TMC114HIV4068
- Acronym
- POISE
- Status last verified
- May 2014
- First submitted
- 6 Jun 2012
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREZISTA or INTELENCE Switch Evaluation in Virologically Suppressed Patients Naïve to Darunavir or Etravirine and Who Are Intolerant of Their Current or Prior Combination Antiretroviral Therapy Regimen: A Phase IV, Open-label, Multicentre Observational Trial
- ClinicalTrials.gov ID
- NCT01615601
- Acronym / sponsor ID
- POISE / CR018595
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Human Immunodeficiency Virus, HIV, HIV-1, HIV type 1, Darunavir, PREZISTA, Etravirine, INTELENCE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Janssen Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Jun 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.
The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are naïve to these medications and in patients who have experienced tolerability issues on their current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by switching the patients from their previous or current combination antiretroviral therapy (cART) to either darunavir or etravirine.
Detailed description
This is an open label (all people know the identity of the intervention.), multicenter (study conducted at multiple sites), observational study (individuals are observed for certain outcomes) of darunavir and etravirine in patients infected with HIV-1 who are naïve to these medications and who have experienced tolerability issues on their current or prior combination antiretroviral therapy (medicines used for treatment of HIV). PREZISTA is indicated for naïve HIV patients (someone who has never used HIV drugs) and treatment-experienced HIV patients and INTELENCE is indicated for treatment-experienced patients who have failed prior therapy and have HIV-1 strains resistant to multiple antiretroviral agents (HIV-1 strains are able to survive the exposure of the multiple antiretroviral agents), including Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs). In this study patients will receive either darunavir (PREZISTA) or etravirine (INTELENCE) and physician selected optimized background agents (other antiretroviral medicines), as permitted by the local formulary and supported by the current Canadian Product Monograph. 90 patients will participate in this study (75 Patients planned for the darunavir group and 15 patients planned for the etravirine group). The total duration of the study will be 24 weeks. Safety and tolerability will be evaluated at screening (14 days prior to Day 1), baseline (patient's medical status before any treatment or research is done) at Day 1, Week 4, Week 12 and Week 24. Tolerability will be evaluated using HIV Symptom Distress Module (HIV-SDM) also referred to as the HIV Symptom Index (HSI) which is a self-completed questionnaire to evaluate symptoms and measure the presence and bothersomeness of side effects commonly seen with HIV and antiretroviral treatment over the last 4 weeks (20 questions about all symptoms which the patient might have had during the past four weeks). Higher scores indicate the presence of more symptoms and/or a greater degree of distress related to the 20 symptoms. In HIV-SDM data is collected to see the benefit of switching to either darunavir or etravirine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| darunavir (PREZISTA) | – | Drug: darunavir (PREZISTA), Drug: ritonavirPREZISTA co-administered with 100 mg ritonavir as per Canadian Product Monograph. (Observational Study) |
| etravirine (INTELENCE) | – | Drug: etravirine (INTELENCE), Drug: Other antiretroviral medicationsINTELENCE co-administered with other antiretroviral medicinal products as per Canadian Product Monograph (Observational Study) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients infected with human immunodeficiency virus type 1 who have experienced tolerability issues on their current or prior ccombination antiretroviral therapy regimen and for whom a regimen including darunavir and/or etravirine is clinically indicated.
Key inclusion criteria (4 listed)
- Have a documented HIV-1 infection
- Have 1 or more significant symptoms with at least grade 2 toxicity on the Division of AIDS Toxicity "DAIDS grading scale" on current or prior combination antiretroviral therapy (cART) regimen (current or prior cART including regimens consisting of 2 Nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent with the exception of darunavir or etravirine)
- Have stable response to current cART ie, have an HIV-plasma viral load [number of virus in blood] at screening <400 copies/mL (undetectable) or last plasma viral load on prior regimen within the previous 6 months <400 copies/mL)
- Must not have resistance to Primary HIV protease inhibitor medicines
Key exclusion criteria (4 listed)
- Has been Infected with HIV-2 - Has received previous treatment with darunavir or etravirine or non-HAART (Highly Active Antiretroviral Therapy) regimen
- Has had prior virologic failure to 2 or more regimens or single virologic failure on prior cART
- Has a documented resistance to darunavir and etravirine
- Is currently using any drug contraindicated in the current Canadian Product Monograph for darunavir or etravirine
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 |
|---|---|---|
| darunavir (PREZISTA)Form = tablet, route = oral, Units = mg, number = 800 administered once daily | Drug | darunavir (PREZISTA) |
| etravirine (INTELENCE)Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily | Drug | etravirine (INTELENCE) |
| ritonavirForm = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily | Drug | darunavir (PREZISTA) |
| Other antiretroviral medicationsGiven as per Canadian Product Monograph | Drug | etravirine (INTELENCE) |
Primary outcome
Change from Baseline in the patient's total score of the HIV Symptom Distress Module (HIV-SDM)
Time frame: Baseline (Day 1), Week 4, 12 and 24
HIV-SDM is a questionnaire consisting of 20 questions related to all the symptoms which the patient might have had during the past four weeks. For each question patient has to select appropriate answer related to the symptoms: "0 = I do not have this symptom; 1 = I have this symptom and it doesn't bother me; 2 = it bothers me a little; 3 = it bothers me; 4 = it bothers me a lot". Total score of HIV-SDM is then calculated for all the 20 items.
5 secondary outcomes
Number of participants with Maintenance/achievement of virologic suppression at Week 24
Time frame: Baseline and Week 24
Number of participants with disappearance by Week 4 of at least one bothersome symptom identified at baseline by patient on HIV-SDM
Time frame: Baseline and Week 4
Number of participants with maintenance of disappearance by Week 12 and Week 24 of at least one bothersome symptom identified at baseline by patient on HIV-SDM
Time frame: Baseline, Week 12 and Week 24
Number of participants with Maintenance/increase in CD4 cell count.
Time frame: Baseline and Week 24
Comparison of change in HIV-SDM scores between those participants who were on or off ARTs at baseline
Time frame: Baseline, Week 4, Week 12 and Week 24
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 22 May 2014.
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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.
Janssen Inc. Clinical Trial study director
Janssen Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV), run by Janssen Inc. at 1 site in Canada.
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 4 inclusion and 4 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
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?
Change from Baseline in the patient's total score of the HIV Symptom Distress Module (HIV-SDM) (time frame: Baseline (Day 1), Week 4, 12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2014.