NCT03195452

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Virus-HIV

Interventions

Type	Name	Description
DRUG	Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)	All virologically suppressed

Timeline

• Start date: 2017-11-08
• Primary completion: 2019-10-30
• Completion: 2020-05-06
• First posted: 2017-06-22
• Last updated: 2020-05-19

Locations

17 sites across 1 country: France