Status:
COMPLETED
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.
Lead Sponsor:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Conditions:
HIV-1 Infection
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00849160
Start Date
May 1 2009
End Date
September 1 2011
Last Update
January 22 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales
Le Kremlin-Bicêtre, France, 94275
2
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne
Paris, France, 75013
3
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
Paris, France, 75013
4
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
Paris, France, 75015