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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Saquinavir; Drug: Fosamprenavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00122603

2005-003470-20

ANRS 127 2 IP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Group 1

Experimental group

Description:

Atazanavir + Fosamprenavir + ritonavir

Treatment:

Drug: Fosamprenavir

group 2

Experimental group

Description:

Atazanavir + saquinavir + ritonavir

Treatment:

Drug: Saquinavir