Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d. Secondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL \> 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
to assess efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
Hôpital Saint Louis
Paris, France
Proportion of patients with therapeutic success, defined as no virological failure
Virological failure is defined as confirmed VL \> 50 cp/mL and no change of the strategy
Time frame: Week 48
Proportions of patients with virological failure (confirmed VL > 50 cp/ml)
Time frame: Week 48
Proportions of patients with VL < 50 cp/ml
Time frame: Week 12, Week 24, Week 36, Week 48
Proportions of patients with VL between 20 and 50 cp/ml
Time frame: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48
Time frame: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood HIV DNA at week 48
Time frame: Week 48
Emerging drug resistance if virological failure
Time frame: Week 48
Treatment adherence
Time frame: Week 48
Change from baseline in blood lipids at week 24 and week 48
Time frame: Week 24 and Week 48
Change from baseline in glucose at week 24 and week 48
Time frame: Week 24 and Week 48
Treatment Digestive tolerance
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Time frame: Week 48