An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

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 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.
    

Intervention name(s): darunavir (PREZISTA); etravirine (INTELENCE); ritonavir; Other antiretroviral medications
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Form = tablet, route = oral, Units = mg, number = 800 administered once daily; Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily; Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily; Given as per Canadian Product Monograph
Intervention MeSH terms: Ritonavir; Darunavir; Etravirine; Anti-Retroviral Agents
Observational model: Cohort
Time perspective: Prospective
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.
      
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),