Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)
NCT ID: NCT00122603
Last Updated: 2011-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2005-12-31
2007-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Atazanavir + Fosamprenavir + ritonavir
Fosamprenavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)
group 2
Atazanavir + saquinavir + ritonavir
Saquinavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)
Interventions
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Fosamprenavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)
Saquinavir
ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)
Eligibility Criteria
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Inclusion Criteria
* 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
* Antiretroviral (ARV) pretreated patients
* Hyperlipidemic treatment
* Evolutive disease
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
GlaxoSmithKline
INDUSTRY
Hoffmann-La Roche
INDUSTRY
French National Agency for Research on AIDS and Viral Hepatitis
OTHER_GOV
Responsible Party
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Principal Investigators
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Roland Landman, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Bichat SMIT A Paris
Jean Pierre Aboulker, MD
Role: STUDY_CHAIR
Inserm SC10
Locations
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Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard
Paris, , France
Countries
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References
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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.
Other Identifiers
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ANRS 127 2 IP
Identifier Type: -
Identifier Source: secondary_id
2005-003470-20
Identifier Type: -
Identifier Source: org_study_id