Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Fosamprenavir; Drug: Saquinavir

• Registration Number: NCT00122603
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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 Timeline

• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Study Start: 2005-12
• Study Completion: 2007-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Fosamprenavir	Atazanavir + Fosamprenavir + ritonavir
group 2	Saquinavir	Atazanavir + saquinavir + ritonavir

Primary Outcome Measures

Name	Time	Method
Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI)
Safety of protease inhibitors
Percentage of patients with viral load below 400 copies/ml at week 16 (W16)

Trial Locations

Locations (1)

Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard; 🇫🇷 Paris, France