Trial | NCT00849160  Report issue

Title

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.
Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    darunavir ...

  • Study Participants

    100
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 Started
May 31
2009
Primary Completion
Jun 30
2011
Study Completion
Sep 30
2011
Last Update
Jan 22
2014
Estimate

Drug darunavir

darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment

Darunavir/r Experimental

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
No Results Posted