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Clinical Pilot, Open, Comparative and Randomized Trial to Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the drug concentration. Moreover, the DRV virtual inhibitory quotient (vIQ) has been related significantly with the virological response to DRV treatment. So patients with a DRV vIQ \>= 1,5 had a 8-times higher probability of having viral load \< 50 copies/mL after 24 weeks of treatment than those having a vIQ \< 1,5. Considering the previous arguments, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a DRV vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Start Date
February 1, 2008
Primary Completion Date
July 1, 2009
Completion Date
July 1, 2009
Last Updated
December 5, 2019
30
ACTUAL participants
Darunavir 900mg + ritonavir 100 mg once a day
DRUG
Darunavir 600mg + ritonavir 100mg twice day
DRUG
Lead Sponsor
Germans Trias i Pujol Hospital
Collaborators
NCT04142047
NCT06694805
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07428330