Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.
- Registration Number
- NCT00849160
- Lead Sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- HIV-1 infected patients
- Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
- At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
- Naiive from darunavir
- Free from any opportunistic infection
- Creatinin < 3N
- ASAT & ALAT < 5N
- Haemoglobin > 7 g/dl
- Platelets > 50 000/mm3
- Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
- Signed informed consent
- HIV-2 infected patients
- Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
- Patients with a documented problem of treatment compliance within the last 12 months
- Ongoing active treatment against any opportunistic infection or tuberculosis
- Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
- Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
- Patient already treated with darunavir
- Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Darunavir/r darunavir -
- Primary Outcome Measures
Name Time Method Undetectable viral load ( < 50 copies/ml) Week 24
- Secondary Outcome Measures
Name Time Method Pharmacologic sub-studies All visits Spermatic viral load (sub-study concerning 15 patients) Day 0 and Week 48 Proportion of patients with undetectable viral load under 50 copies/ml 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. All visits CD4 lymphocytes count and evolution All visits Lipids balance evolution All visits Treatment tolerance All visits Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures. All visits
Trial Locations
- Locations (5)
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
🇫🇷Paris, France
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
🇫🇷Paris, France
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