Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain. Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales
Le Kremlin-Bicêtre, France
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne
Paris, France
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
Paris, France
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
Paris, France
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
Paris, France
Undetectable viral load ( < 50 copies/ml)
Time frame: Week 24
Proportion of patients with undetectable viral load under 50 copies/ml
Time frame: All visits
Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.
Time frame: All visits
CD4 lymphocytes count and evolution
Time frame: All visits
Lipids balance evolution
Time frame: All visits
Treatment tolerance
Time frame: All visits
Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.
Time frame: All visits
Spermatic viral load (sub-study concerning 15 patients)
Time frame: Day 0 and Week 48
Pharmacologic sub-studies
Time frame: All visits
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