Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916, Spain
NCT Number: NCT00611039
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Badalona, Barcelona, 08916, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 600mg + ritonavir 100mg twice day
Time frame: Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: Screening, Basal, week 12, week 24, week 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Time frame: When virological failure
Germans Trias i Pujol Hospital
Other
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
Acronym: DRV900100QD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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