Study of Bictegravir/Emtricitavine/Tenofovir alafenamide in HIV-1 infected naïve patients using test and treat stategy rapid-initiation model of care: BIC-NOW clinical trial (BIC-NOW)

Study type

• Study type:
  Clinical trial

Study drug and medical condition

• Name of medicine:
  BIKTARVY

Population studied

• 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)
• Estimated number of subjects:
  208

Study design details

• Main study objective:
  To analyze antiviral activity of BIC/FTC/TAF at 24 and 48 weeks in HIV-1-infected, ART-naive subjects, using test and treat strategy.
• Outcomes:
  Proportion of subjects with plasma HIV-1 RNA <50 copies/mL at week 24 AND 48 using FDA Snapshot algorithm. There are secondary clinical outcomes and implementation outcomes. Demographics Full blood haemogram and chemistry Serology Patient reported outcomes (PROs) FAT DEXA
• Data analysis plan:
  Descriptions of the principal variables collected in the study were, for the quantitative variables, measures of central tendencies and dispersion: mean, standard deviation, median, percentiles, and for the qualitative variables, absolute and relative frequencies. To assess the effectivity, subjects response with VL<50copies/mL will be analyzed. Effectivity results will be compared among patients classified as immediate treatment and those classified as fast treatment. At least three analyses will be performed to assess endpoints when every subject completed the week 4, 24 and 48, being the primary analysis at week 48.