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Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Jul 17, 2013, no change to tracked fieldsv11-v12
  2. Primary completion date changed from estimate of Jul 2009 to Jun 2010 Study completion date changed from estimate of Apr 2010 to Feb 2011 · Trial status: Active, Not Recruiting to Completedv10 Show 2 more changesShow less
    • Study completion date changed from estimate of Apr 2010 to Feb 2011
    • Trial status: Active, Not Recruiting to Completed
  3. Enrollment target: estimated 220 to confirmed 225 Primary completion date: Jul 2010 to Jul 2009 · Completion date: Dec 2010 to Apr 2010 · Secondary endpoints: 15 to 16v9 Show 3 more changesShow less
    • Primary completion date: Jul 2010 to Jul 2009
    • Completion date: Dec 2010 to Apr 2010
    • Secondary endpoints: 15 to 16

    See this version in full on ClinicalTrials.gov ↗

  4. Study title expanded, about 1 wordv8 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Recruiting to Active, Not Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jul 2010 Completion date: Dec 2010 · Study arms: 0 to 2 · Eligibility criteria expanded, about 2 wordsv6 Show 3 more changesShow less
    • Completion date: Dec 2010
    • Study arms: 0 to 2
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  3. 2 versions Re-verified since Jan 29, 2007, no change to tracked fieldsv3-v4
  4. Study title revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.
Trial Details
NCT Number NCT00421551
Lead Sponsor French National Agency for Research on AIDS and Viral Hepatitis
Collaborators: Tibotec Pharmaceutical Limited
Conditions HIV Infections
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov