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