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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Protease inhibitor naive patients
- •Wild type genotype
- •CD4 greater than 200/mm3
- •Viral load between 10,000 copies/ml and 750,000 copies/ml
- •Signed informed consent
Exclusion Criteria
- •Pregnancy; breast feeding
- •Antiretroviral (ARV) pretreated patients
- •Hyperlipidemic treatment
- •Evolutive disease
Arms & Interventions
Group 1
Atazanavir + Fosamprenavir + ritonavir
Intervention: Fosamprenavir (Drug)
group 2
Atazanavir + saquinavir + ritonavir
Intervention: Saquinavir (Drug)
Outcomes
Primary Outcomes
Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
Secondary Outcomes
- Safety of protease inhibitors
- Percentage of patients with viral load below 400 copies/ml at week 16 (W16)
- Body mass index (BMI)