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

This study has been completed.

Sponsor:

Collaborators:

Bristol-Myers Squibb

GlaxoSmithKline

Hoffmann-La Roche

Information provided by (Responsible Party):

French National Agency for Research on AIDS and Viral Hepatitis

ClinicalTrials.gov Identifier:

NCT00122603

First received: July 19, 2005

Last updated: December 21, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2005

Last Updated Date

December 21, 2011

Start Date ^ICMJE

December 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00122603 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Safety of protease inhibitors
Percentage of patients with viral load below 400 copies/ml at W16
BMI

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Group 1
Atazanavir + Fosamprenavir + ritonavir

Intervention: Drug: Fosamprenavir
Experimental: group 2
Atazanavir + saquinavir + ritonavir

Intervention: Drug: Saquinavir

Publications *

Landman R, Capitant C, Descamps D, Chazallon C, Peytavin G, Katlama C, Pialoux G, Bentata M, Brun-Vézinet F, Aboulker JP, Yéni P; ANRS 127 Study Group. Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. J Antimicrob Chemother. 2009 Jul;64(1):118-25. doi: 10.1093/jac/dkp146. Epub 2009 May 6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00122603

Other Study ID Numbers ^ICMJE

2005-003470-20, ANRS 127 2 IP

Has Data Monitoring Committee

Yes

Responsible Party

French National Agency for Research on AIDS and Viral Hepatitis

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Bristol-Myers Squibb
GlaxoSmithKline
Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:	Roland Landman, MD	Hopital Bichat SMIT A Paris
Study Chair:	Jean Pierre Aboulker, MD	Inserm SC10

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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