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COMPLETED
NCT03195452
PHASE2

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2017-11-08

Completion Date

2020-05-06

Last Updated

2026-09-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

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

All virologically suppressed

Locations (17)

CHU De Bordeaux

Bordeaux, France

CH de la Roche Sur Yon

La Roche-sur-Yon, France

CH du Mans

Le Mans, France

CHU de Lyon

Lyon, France

CHRU de Montpellier

Montpellier, France

CHU of NANTES

Nantes, France

CHU de Nice

Nice, France

CHR orléans

Orléans, France

CHU de Bichat

Paris, France

CHu hotel dieu

Paris, France

CHU la pitié

Paris, France

Hopital Avicenne

Paris, France

Hopital Necker

Paris, France

Hopital St Louis

Paris, France

CHU de Reims

Reims, France

CH de Tourcoing

Tourcoing, France

CHRU de Tours

Tours, France