Phase IIa, open clinical trial, pilot, single arm and proof of concept.
Name: Dolutegravir (DTG)
Name: Lamivudine (3TC)
Description: - Efficacy: Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.
Measure: Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks Time: Week 48Description: Proportion of patients with viral load <50 copies/ml at week 24, according to the FDA snapshot algorithm in the population "by intention to treat-exposed".
Measure: Proportion of patients with virological failure at 24 weeks Time: Week 24Description: Proportion of patients with virological failure at week 48 according to the FDA snapshot algorithm.
Measure: Proportion of patients with virological failure at 48 weeks Time: Week 48Description: Incidence of adverse events and discontinuation of treatment due to toxicity or intolerance.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: Since baseline visits to week 48Description: Incidence of genotypic resistance mutations in patients with virological failure at week 48. Description and frequency of genotypic resistance mutations.
Measure: Evaluation of the appearance of genotypic resistance mutations (1) Time: Week 48Allocation: N/A
Single Group Assignment
There are 2 SNPs
For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations. --- M184V --- --- K65R ---
For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations. --- M184V --- --- K65R ---
Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N. --- M184V --- --- K65R ---
Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA. --- M184V --- --- K65R ---
For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations. --- M184V ---
For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations. --- M184V ---
Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N. --- M184V ---
Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA. --- M184V ---