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Early Infant HIV Treatment in Botswana

Study acronym: EIT
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Publications: details revised at 11 of 11 entriesv12
  2. Collaborators: 3 to 4
    • Publications: details revised at 11 of 11 entries
    v11
  3. Publications: 10 to 11v10
  4. Start date: Feb 2015 to May 4, 2015v9 Show 7 more changesShow less
    • Enrollment target: estimated 75 to confirmed 67
    • Study sites: 4 to 1
    • Primary completion date changed from estimate of May 2022 to Nov 6, 2020
    • Study completion date: May 2022 to Jun 30, 2029
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints expanded, about 42 words
    • Publications: 68 to 10
  5. Primary and study completion dates: May 2021 to May 2022v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v7
  2. Primary completion date: Jul 2020 to May 2021v6 Show 4 more changesShow less
    • Enrollment target: 70 to 75
    • Study completion date: Jul 2021 to May 2021
    • Publications: 67 to 68
    • Eligibility criteria expanded, about 4 words
  3. Primary completion date: Feb 2019 to Jul 2020
    • Study completion date: Feb 2019 to Jul 2021
    v5
  4. 2 versions Re-verified since Mar 7, 2016, no change to tracked fieldsv3-v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 overall objective of this study is to determine whether very early antiretroviral treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and maintains immune responses, potentially allowing future periods off ART.
Trial Details
NCT Number NCT02369406
Lead Sponsor Harvard School of Public Health (HSPH)
Collaborators: Ragon Institute of MGH, MIT and Harvard, Brigham and Women's Hospital, Botswana Harvard Health Partnership, University of California, San Diego
Conditions
(from sponsor)		 HIV, Pediatric AIDS
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov