WISARD
An Open-label, multi-centre, randomised, switch study to evaluate the virological efficacy over 96 weeks of 2-Drug therapy with DTG/RPV FDC in Antiretroviral treatmentexperienced HIV-1 infected subjects virologically suppressed with Nnrtis Resistance Mutation K103N
Project Details
Start Date
2019
End Date
2021
Status
Ongoing
Main Research Site
RIDU
Main objective of the trial:
- To compare efficacy of DTG/RPV combined tablet versus continued antiretroviral treatment regimen at 48 weeks in individuals with the K103N resistance mutation.
Secondary objectives of the trial:
- To investigate whether switching patients to DTG/RPV FDC is associated with improvement of lipid profile, patient satisfaction, quality of life and potential for drug-drug interactions, investigated over time through 96 weeks with evaluation (and comparison to control arm) at week 24, 48 and 96.
- To evaluate DTG & RPV concentrations in blood.
- To evaluate changes in cell associated virus.
MAIN FUNDING BODY
