Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)
|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
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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|
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.
|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|
|Study Arm (s)||
|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 Status ICMJE||Completed|
|Completion Date||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|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|
|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|
|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