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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Fosamprenavir

Saquinavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Protease Inhibitors, HIV infections, Atazanavir, Saquinavir, Fosamprenavir, ritonavir, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

group 2

Arm Description

Atazanavir + Fosamprenavir + ritonavir

Atazanavir + saquinavir + ritonavir

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of protease inhibitors

Percentage of patients with viral load below 400 copies/ml at week 16 (W16)

Body mass index (BMI)

Full Information

NCT ID

NCT00122603

First Posted

July 19, 2005

Last Updated

December 21, 2011

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00122603

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV Protease Inhibitors, HIV infections, Atazanavir, Saquinavir, Fosamprenavir, ritonavir, Treatment Naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Atazanavir + Fosamprenavir + ritonavir

Arm Title

group 2

Arm Type

Experimental

Arm Description

Atazanavir + saquinavir + ritonavir

Intervention Type

Drug

Intervention Name(s)

Fosamprenavir

Intervention Description

ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)

Intervention Type

Drug

Intervention Name(s)

Saquinavir

Intervention Description

ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Safety of protease inhibitors

Title

Percentage of patients with viral load below 400 copies/ml at week 16 (W16)

Title

Body mass index (BMI)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roland Landman, MD

Organizational Affiliation

Hopital Bichat SMIT A Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean Pierre Aboulker, MD

Organizational Affiliation

Inserm SC10

Official's Role

Study Chair

Facility Information:

Facility Name

Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard

City

Paris

ZIP/Postal Code

75018

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

19420019

Citation

Landman R, Capitant C, Descamps D, Chazallon C, Peytavin G, Katlama C, Pialoux G, Bentata M, Brun-Vezinet F, Aboulker JP, Yeni 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.

Results Reference

derived

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

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