SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03195452

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very interesting for patient with comorbidities and comedications, intolerance or toxicities with their current ARV treatment. However its current formulation of one tablet of 400mg twice a day coul not suit many patients. A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD. Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL exposure compared to the standard formulation of 400 mg given twice a day. The objective of this study is to evaluate the maintain of virologic suppression with raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically controlled patients.

NCT03195452 Virus-HIV
MeSH:Acquired Immunodeficiency Syndrome HIV Infections

1 Interventions

Name: Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)

Description: All virologically suppressed
Type: Drug
Group Labels: 1

Raltegravir


Primary Outcomes

Measure: Number of copie/ml plasma HIV - RNA

Time: 48 weeks

Secondary Outcomes

Measure: Score evaluation of patient satisfaction

Time: 48 weeks

Measure: Score evaluation of patient quality of life with PROQOL-HIV questionnaires

Time: 48 weeks

Measure: Score evaluation of adherence

Time: 48 weeks

Measure: Number of incidence of Treatment-Emergent Adverse Events

Time: 48 weeks

Measure: Number of patient who have a viral load < 50 copies/ml

Time: 48 weeks

Measure: number of discontinuation of Raltegravir

Time: 48 weeks

Measure: number of treatment failure

Time: 48 weeks

Measure: number of genotype resistance mutations

Time: 48 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 E138A

- Presence of possible resistance or resistance to any non- nucleoside reverse transcriptase inhibitor on a historical plasma genotype, with the exception of polymorphic mutations E138A/G/K/Q/R/S and V179D in patients naïve to NNRTI. --- E138A ---


2 V179D

- Presence of possible resistance or resistance to any non- nucleoside reverse transcriptase inhibitor on a historical plasma genotype, with the exception of polymorphic mutations E138A/G/K/Q/R/S and V179D in patients naïve to NNRTI. --- E138A --- --- V179D ---



HPO Nodes