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.
Information source: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1 Infection; HIV Infections
Intervention: darunavir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida Official(s) and/or principal investigator(s): Jade Ghosn, MD, Principal Investigator, Affiliation: Centre Hsopitalier Universitaire de Bicêtre Christine Katlama, MD, Study Director, Affiliation: Groupe Hospitalier Pitié-Salpêtrière
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.
Clinical Details
Official title: 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.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Undetectable viral load ( < 50 copies/ml)
Secondary outcome: Proportion of patients with undetectable viral load under 50 copies/mlProportion 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. CD4 lymphocytes count and evolution Lipids balance evolution Treatment tolerance Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures. Spermatic viral load (sub-study concerning 15 patients) Pharmacologic sub-studies
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales, Le Kremlin Bicêtre 94275, France
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne, Paris 75013, France
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales, Paris 75013, France
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales, Paris 75015, France
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales, Paris 75020, France
Additional Information
Starting date: May 2009
Last updated: January 21, 2014
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