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

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.

Timeline

Start

2017-11-08

Primary completion

2019-10-30

Completion

2020-05-06

Publications

• Hall N, Allavena C, Katlama C, Jobert A, Molina JM, Cua E, Bani-Sadr F, Hocqueloux L, Duvivier C, Merrien D, Hikombo H, Andre-Garnier E, Gaultier A, Raffi F; QDISS Study Group. Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial. AIDS Res Ther. 2022 Jan 15;19(1):4. doi: 10.1186/s12981-022-00428-5.

Drugs

Indications