Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)
The purpose of this study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Regimens Restricted to a Combination of Two Boosted Protease Inhibitors as Potent Antiretroviral Therapy in HIV-1 Infected Patients. ANRS 127 2IP|
- Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
- Safety of protease inhibitors
- Percentage of patients with viral load below 400 copies/ml at week 16 (W16)
- Body mass index (BMI)
|Study Start Date:||December 2005|
|Study Completion Date:||August 2007|
Experimental: Group 1
Atazanavir + Fosamprenavir + ritonavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)
Experimental: group 2
Atazanavir + saquinavir + ritonavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)
The purpose of this randomized, open-label study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.
Patients with CD4 cell counts over or equal to 200/mm3, HIV viral load between 10,000 and 750,000 copies per milliliter, and wild-type genotype at baseline will be eligible. This multicenter study will enroll 60 patients (n=30 in each group). The planned duration of the study is 48 weeks from the enrolment of the last subject.
The primary efficacy endpoint will be virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks.
The primary safety endpoint will be treatment interruptions because of adverse effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122603
|Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard|
|Paris, France, 75018|
|Principal Investigator:||Roland Landman, MD||Hopital Bichat SMIT A Paris|
|Study Chair:||Jean Pierre Aboulker, MD||Inserm SC10|