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

Tracking Information
First Submitted Date ICMJE	July 19, 2005
First Posted Date ICMJE	July 22, 2005
Last Update Posted Date	December 22, 2011
Study Start Date ICMJE	December 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: July 20, 2005)	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; (submitted: July 27, 2005)	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; (submitted: July 20, 2005)	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; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: December 21, 2011)	61
Original Enrollment ICMJE; (submitted: July 20, 2005)	60
Actual Study 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
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
PRS Account	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