HIV Infections Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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