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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Enrollment target: estimated 60 to confirmed 61
    • Interventions: atazanavir (Drug), fosamprenavir (Drug), ritonavir (Drug), saquinavir (Drug) to Fosamprenavir (Drug), Saquinavir (Drug)
    • Study arms: 0 to 2
    v10
  3. Study title expanded, about 1 wordv9
  4. Trial status: Active, Not Recruiting to Completed
    • Study completion date: Aug 2007
    v8
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study site revisedv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2005 to Dec 2005
    • Study site revised
    v5
  3. 2 versions Re-verified since Jul 28, 2005, no change to tracked fieldsv3-v4
  4. Phase: Phase 3 to Phase 2v2 Show 4 more changesShow less
    • Secondary endpoints revised (3)
    • Study description revised
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 4 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00122603
Lead Sponsor French National Agency for Research on AIDS and Viral Hepatitis
Collaborators: Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche
Conditions
(from sponsor)		 HIV Infections
Related terms HIV Infections
Enrollment 61 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov