SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02629822

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations

The primary objectives of this study are to evaluate the antiretroviral activity and to evaluate the safety and tolerability of open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg in treatment-naive HIV-1 infected participants with selected NNRTI transmitted resistance mutations.

NCT02629822 HIV-1 Infection
MeSH: Acquired Immunodeficiency Syndrome HIV Infections

1 Interventions

Name: MK-1439A

Description: A single FDC tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg will be administered orally, once daily for up to 96 weeks. For some participants who continue into the study extension, study treatment will continue for an additional 96 weeks, approximately, through a total of approximately 192 weeks of treatment.

Type: Drug

HIV-1 Infected

Primary Outcomes

Measure: Percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48

Time: Week 48

Measure: Number of participants with one or more adverse event (AE)

Time: Up to Week 96

Measure: Number of participants who discontinued treatment due to an AE

Time: Up to Week 96
Purpose: Treatment

Single Group Assignment

There are 3 SNPs

SNPs

1 G190A

- Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A. --- K103N --- --- Y181C --- --- G190A ---

2 K103N

- Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A. --- K103N ---

3 Y181C

- Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A. --- K103N --- --- Y181C ---


HPO Nodes