SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03539224

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.

Phase IIa, open clinical trial, pilot, single arm and proof of concept.

NCT03539224 HIV-1-infection

2 Interventions

Name: Dolutegravir (DTG)

Description: DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks

Type: Drug

Dolutegravir (DTG) + Lamivudine (3TC)

Name: Lamivudine (3TC)

Description: Lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks.

Type: Drug

Dolutegravir (DTG) + Lamivudine (3TC)


Primary Outcomes

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 48

Secondary Outcomes

Description: 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 24

Description: 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 48

Description: 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 48

Description: 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 48

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 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 --- --- 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 ---


2 M184V

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 ---



HPO Nodes