- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615601
An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients (POISE)
May 20, 2014 updated by: Janssen Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vancouver, Canada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
darunavir (PREZISTA)
PREZISTA co-administered with 100 mg ritonavir as per Canadian Product Monograph.
(Observational Study)
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Form = tablet, route = oral, Units = mg, number = 800 administered once daily
Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily
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etravirine (INTELENCE)
INTELENCE co-administered with other antiretroviral medicinal products as per Canadian Product Monograph (Observational Study)
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Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily
Given as per Canadian Product Monograph
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline (Day 1), Week 4, 12 and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Maintenance/achievement of virologic suppression at Week 24
Time Frame: Baseline and Week 24
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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.
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Baseline and Week 24
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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
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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.
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Baseline and Week 4
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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
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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.
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Baseline, Week 12 and Week 24
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Number of participants with Maintenance/increase in CD4 cell count.
Time Frame: Baseline and Week 24
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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.
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Baseline and Week 24
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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
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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.
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Baseline, Week 4, Week 12 and Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
June 6, 2012
First Submitted That Met QC Criteria
June 6, 2012
First Posted (ESTIMATE)
June 8, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 22, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Darunavir
- Etravirine
- Anti-Retroviral Agents
Other Study ID Numbers
- CR018595
- TMC114HIV4068 (OTHER: Janssen Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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