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.

Last updated: January 21, 2014
Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT00849160
CREPATS 001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HIV-1 infected patients

  • Treatment with an association of 3 molecules including two Nucleotidic ReverseTrasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged forat 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 mechaniccontraceptive during sexual relationships

  • Signed informed consent

Exclusion

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 jeopardizetreatment compliance and/olr tolerance, and interfere with the protocol compliance

  • Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-basedenzymes

  • Patient already treated with darunavir

  • Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/ormaraviroc

Study Design

Total Participants: 100
Study Start date:
May 01, 2009
Estimated Completion Date:
September 30, 2011

Connect with a study center

  • Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales

    Le Kremlin Bicêtre, 94275
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales

    Le Kremlin Bicêtre, 94275
    France

    Site Not Available

  • Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne

    Paris, 75013
    France

    Site Not Available

  • Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales

    Paris, 75013
    France

    Site Not Available

  • Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales

    Paris, 75015
    France

    Site Not Available

  • Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

    Paris, 75020
    France

    Site Not Available

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