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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122603
• Other study ID #: 2005-003470-20
• Secondary ID: ANRS 127 2 IP
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2005
• Last updated: December 21, 2011
• Start date: December 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Fosamprenavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)
• Saquinavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)

Locations

Country	Name	City	State
France	Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard	Paris

Sponsors (4)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
Secondary	Safety of protease inhibitors
Secondary	Percentage of patients with viral load below 400 copies/ml at week 16 (W16)
Secondary	Body mass index (BMI)