Real-life study of single tablet regimen (STR) and multi tablet regimen (MTR) usage in Germany on persistency of initial therapy - STRingent

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Persistency of initial ART
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AE) Protease inhibitors

  Protease inhibitors

  (J05AF) Nucleoside and nucleotide reverse transcriptase inhibitors

  Nucleoside and nucleotide reverse transcriptase inhibitors

  (J05AG) Non-nucleoside reverse transcriptase inhibitors

  Non-nucleoside reverse transcriptase inhibitors

  (J05AR) Antivirals for treatment of HIV infections, combinations

  Antivirals for treatment of HIV infections, combinations

  (J05AX) Other antivirals

  Other antivirals
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  Antiretroviral therapy naive, HIV-1 infected adult patients in Germany who start their first anti-retroviral therapy either with a single tablet regimen (STR) or multi tablet regimen (MTR).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  365

Study design details

• Main study objective:
  To evaluate persistency of initial HIV therapy in subjects starting with STR or MTR during the first year of therapy
• Outcomes:
  To evaluate persistency of initial HIV therapy in subjects starting with STR or MTR during the first year of therapy. characteristics of HIV-infected subjects with initial therapy,treatment motivation and the specific treatment regimen (STR or MTR)STR/MTR efficacy regarding HIV-RNA and CD4 cell count changesadherence to ART medicationreasons for treatment discontinuation or change of therapyquality of life and health status (SF36, HIV Symptom Index)adverse drug reactions
• Data analysis plan:
  We will employ descriptive statistics and multivariable analyses adjusting for relevant confounders and appropriate statistical tests. These include:Binary/categorical/ordinal variables: Frequency distributions using Chi-square tests and Fisher’s exact tests.Continuous variables: Comparison of means (+ 95% CI) using t tests, and comparison of medians (+ IQR) using non-parametric tests.Rates of events by person-time of exposure to either MTR or STR will be computed using Poisson regression, adjusting for confounding variables.