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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv11
  2. Minor 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 2v10 Show all 3 changesShow less
    • Interventions: atazanavir (Drug), fosamprenavir (Drug), ritonavir (Drug), saquinavir (Drug) to Fosamprenavir (Drug), Saquinavir (Drug)
    • Study arms: 0 to 2
  3. Minor Study title expanded, about 1 wordv9 Show moreShow less
  4. Minor Trial status: Active, Not Recruiting to Completed Completion date: Aug 2007v8 Show all 2 changesShow less
    • Completion date: Aug 2007
  5. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv7 Show all 2 changesShow less
    • Site details revised
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Study site revisedv6 Show moreShow less
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2005 to Dec 2005 · Study site revisedv5 Show all 3 changesShow less
    • Start date: Sep 2005 to Dec 2005
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Minor 2 versions Re-verified since Jul 28, 2005, no change to tracked fieldsv3-v4
  4. Notable Phase: Phase 3 to Phase 2 Secondary endpoints revised (3) · Study description revised · Eligibility criteria expanded, about 2 words · 1 morev2 Show all 5 changesShow less
    • Secondary endpoints revised (3)
    • Study description revised
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 HIV Infections
Enrollment 61 participants
Start Date
Study Completion (estimated)
Updated on ClinicalTrials.gov