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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
• Treatments: Darunavir; HIV Protease Inhibitors; Protease Inhibitors

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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