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Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications expanded, about 71 wordsv15 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  2. Interventions: efavirenz or lopinavir/r (Drug), emtricitabine/tenofovir disoproxil fumarate (Drug), enfuvirtide (Drug) to emtricitabine/tenofovir (Drug), enfuvirtide (Drug), lopinavir or efavirenz (Drug) Eligibility criteria expanded, about 5 words · Study description expanded, about 2 wordsv14 Show all 3 changesShow less
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv13
  4. Trial status: Active, Not Recruiting to Completed Primary completion date changed from estimate of Jul 2009 to Dec 2009v12 Show all 2 changesShow less
    • Primary completion date changed from estimate of Jul 2009 to Dec 2009
  5. Enrollment target: estimated 220 to confirmed 195v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study title expanded, about 1 wordv10 Show moreShow less

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  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv9 Show all 2 changesShow less
    • Site details revised
  3. Eligibility criteria expanded, about 1 wordv8 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Sep 2009 to Jul 2009 Completion date: Sep 2009 to Dec 2009 · Secondary endpoints: details revised at 1 of 1 entry · Study arms: 0 to 2v7 Show all 4 changesShow less
    • Completion date: Sep 2009 to Dec 2009
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 0 to 2
  5. Primary completion date: Sep 2009 Completion date: Jan 2009 to Sep 2009v6 Show all 2 changesShow less
    • Completion date: Jan 2009 to Sep 2009
  6. Completion date: Jan 2007 to Jan 2009v5
  7. Completion date: Jan 2007v4
  8. Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show all 2 changesShow less
    • Site details revised
  9. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity. The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment. We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.
Trial Details
NCT Number NCT00302822
Lead Sponsor French National Agency for Research on AIDS and Viral Hepatitis
Collaborators: Hoffmann-La Roche, Gilead Sciences
Conditions HIV Infections, AIDS
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov