Dual Boosted Protease Inhibitor Regimens Without Any Addi... | NCT00122603

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

NCT00122603

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Status

Completed

Last Update Posted

Apr 2, 2026Actual

Enrollment

61Actual

Phase

Phase 2

Conditions

HIV Infections

Interventions

Fosamprenavir
Saquinavir

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005-003470-20	EudraCT Number

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Jul 19, 2005

First Submission Date that Met QC Criteria

Jul 20, 2005

First Posted Date

Jul 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2026

Last Update Posted Date

Apr 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

French National Agency for Research on AIDS and Viral HepatitisOTHER_GOV

Collaborators

Name	Class
Bristol-Myers Squibb	INDUSTRY
GlaxoSmithKline	INDUSTRY
Hoffmann-La Roche	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	Atazanavir + Fosamprenavir + ritonavir	Drug: Fosamprenavir
group 2	Experimental	Atazanavir + saquinavir + ritonavir	Drug: Saquinavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fosamprenavir	Drug	ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)	Group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard		Paris		75018	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19420019	Derived	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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
C426859	fosamprenavir
D019258	Saquinavir