An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients (POISE)
|ClinicalTrials.gov Identifier: NCT01615601|
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : May 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus (HIV)||Drug: darunavir (PREZISTA) Drug: etravirine (INTELENCE) Drug: ritonavir Drug: Other antiretroviral medications||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||77 participants|
|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|
|Study Start Date :||October 2011|
|Primary Completion Date :||April 2013|
|Study Completion Date :||April 2013|
PREZISTA co-administered with 100 mg ritonavir as per Canadian Product Monograph. (Observational Study)
Drug: darunavir (PREZISTA)
Form = tablet, route = oral, Units = mg, number = 800 administered once dailyDrug: ritonavir
Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily
INTELENCE co-administered with other antiretroviral medicinal products as per Canadian Product Monograph (Observational Study)
Drug: etravirine (INTELENCE)
Form = tablet, route = oral, Unit = mg, number = 200, administered twice dailyDrug: Other antiretroviral medications
Given as per Canadian Product Monograph
- 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.
- Number of participants with Maintenance/achievement of virologic suppression at Week 24 [ Time Frame: Baseline and 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.
- 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 ]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.
- 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 ]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.
- Number of participants with Maintenance/increase in CD4 cell count. [ Time Frame: Baseline and Week 24 ]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.
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615601
|Study Director:||Janssen Inc. Clinical Trial||Janssen Inc.|