Post-marketing study to assess the effectiveness of doravirine-included in highly active antiretroviral therapy (HAART) in HIV-1 infected adult Chinese patients (MK-1439-088)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective multi-center observational study

Study drug and medical condition

• Name of medicine:
  PIFELTRO
• Study drug International non-proprietary name (INN) or common name:
  DORAVIRINE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AG06) doravirine

  doravirine
• Medical condition to be studied:
  HIV infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  350

Study design details

• Main study objective:
  The primary objective is to assess the effectiveness of doravirine-included HAART in HIV-1 infected adult Chinese participants.
• Outcomes:
  Virologic suppression (VS, HIV-1 RNA< 50 copies/mL) achieved at week 48±8 following PIFELTRO™ and DELSTRIGO™ administration. ; Demographics, clinical characteristics and HIV-1 treatment patterns in the study population.
• Data analysis plan:
  A descriptive analysis will be conducted. For the continuous variables we are interested, the values of mean/median, standard deviation (SD), min/max, interquartile range (IQR, including the first quartile Q1 and third quartile Q3) will be calculated, the frequency and percentages will be calculated for these categorical variables. ; Effectiveness will be assessed as the proportion of patients with VS at week 48±8 will be calculated with a 95% CI.

Documents

Study report

MK-1439 P088 CSR_final-redaction.pdf