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.

HIV Infections Clinical Trial

— RADAR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849160
• Other study ID #: CREPATS 001
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2009
• Last updated: January 21, 2014
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2014
• Source: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV-1 Infection
• Infection

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales	Le Kremlin Bicêtre
France	Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne	Paris
France	Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales	Paris
France	Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales	Paris
France	Hôpital Tenon - Service des Maladies Infectieuses et Tropicales	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable viral load ( < 50 copies/ml)		Week 24	No
Secondary	Proportion of patients with undetectable viral load under 50 copies/ml		All visits	No
Secondary	Proportion 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.		All visits	No
Secondary	CD4 lymphocytes count and evolution		All visits	No
Secondary	Lipids balance evolution		All visits	No
Secondary	Treatment tolerance		All visits	Yes
Secondary	Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.		All visits	No
Secondary	Spermatic viral load (sub-study concerning 15 patients)		Day 0 and Week 48	No
Secondary	Pharmacologic sub-studies		All visits	No