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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

July 19, 2005
December 21, 2011
December 2005
Not Provided
Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
Same as current
Complete list of historical versions of study NCT00122603 on ClinicalTrials.gov Archive Site
  • Safety of protease inhibitors
  • Percentage of patients with viral load below 400 copies/ml at week 16 (W16)
  • Body mass index (BMI)
  • Safety of protease inhibitors
  • Percentage of patients with viral load below 400 copies/ml at W16
  • BMI
Not Provided
Not Provided
 
Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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)
  • Experimental: Group 1
    Atazanavir + Fosamprenavir + ritonavir
    Intervention: Drug: Fosamprenavir
  • Experimental: group 2
    Atazanavir + saquinavir + ritonavir
    Intervention: Drug: Saquinavir
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. Epub 2009 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
August 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122603
2005-003470-20, ANRS 127 2 IP
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
  • Bristol-Myers Squibb
  • GlaxoSmithKline
  • Hoffmann-La Roche
Principal Investigator: Roland Landman, MD Hopital Bichat SMIT A Paris
Study Chair: Jean Pierre Aboulker, MD Inserm SC10
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

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