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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 600mg + ritonavir 100mg twice day
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Proportion of patients with HIV-1 viral load < 50 copies /mL
Time frame: Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48
DRV plasma trough concentration
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
DRV Virtual inhibitory quotient (vIQ)
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
CD4 and CD8 lymphocytes count
Time frame: Screening, Basal, week 12, week 24, week 36 and week 48
Physical examination including weight and height
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Karnofsky index
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
Adverse events
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Treatment adherence (assessed by the physician, but not recovered in the data base)
Time frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Genotype, if virological failure occurs
Time frame: When virological failure
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