The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.
This is a 48-week, Phase IV, randomized, open-label, to assess the non-inferior antiviral activity (VL \< 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV1 naïve adult patients without baseline GT available at Day 1 visit. Subjects will be stratified by screening HIV-1 RNA (≤100,000 c/mL or \>100,000 c/mL) and Screening CD4+ cell count (≤ or \>200 cells/mm3). The study will comprise: * a 28-day Screening Phase (which may be extended to 35 days to allow receipt of all Screening assessment results). * an Open-label Randomized Phase (Day 1 to Week 48). Approximately 200 HIV-1 naïve adult patients will be randomized 1:1 to receive 2DR DTG+3TC versus 3DR TDF/FTC + DTG for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Experimental arm
Active Comparator
Fundacion IDEAA
Buenos Aires, Argentina
Virologic Efficacy
To demonstrate the non-inferior antiviral activity (VL \< 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV-1 naïve adult patients without baseline genotypic resistance testing available. Endpoint: Proportion of subjects with plasma HIV-1 RNA \<50 copies/mL (c/mL) at Week 48 using the FDA Snapshot algorithm \[Missing, Switch or Discontinuation = Failure (MSD=F)\] for the intent-to-treat exposed (ITT-E) population.
Time frame: 48 weeks
Genetic barrier
To assess the selection / emergence of viral resistance in subjects meeting confirmed virologic withdrawal (CVW) criteria. Endpoint: incidence of treatment-emergent genotypic resistance to DTG and 3TC or TDF/FTC in subjects meeting CVW criteria.
Time frame: 48 weeks
Efficacy in presence of any major resistanceassociated mutation al baseline
To evaluate the antiviral activity of DTG + 3TC compared to DTG + TDF/FTC over time in patients with pre-existing viral resistance based on the presence of any major resistanceassociated mutation (IAS-USA 2019). Endpoint: Proportion of subjects with plasma HIV-1 RNA \<50 copies/mL (c/mL) at Week 48 using the FDA Snapshot algorithm and The proportion of participants with HIV-1 RNA \<50 or \<200 copies/mL using the observed algorithm (excluding participants with missing data) in patients with pre-existing viral resistance based on the presence of any major resistance-associated mutation (IAS-USA 2019).
Time frame: 48 weeks
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