Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05393193 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

POC HIV Testing and Early DTG Use for Infants

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from May 31, 2026 to Mar 16, 2026
    • Study completion pushed from Aug 31, 2026 to Dec 31, 2026
    v8
  2. Study site revisedv7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Study title revised
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Eligibility criteria revisedv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 20, 2022 to Jul 4, 2022
    • Site details revised
    v3
  2. Start date: Jun 1, 2022 to Jun 20, 2022
    • Interventions: DTG/ZDV/3TC (Drug), Point-of-Care Cepheid Xpert HIV-1 (Diagnostic Test) to DTG/ABC/3TC (Drug), Point-of-Care Cepheid Xpert HIV-1 (Diagnostic Test)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.
Trial Details
NCT Number NCT05393193
Lead Sponsor Harvard School of Public Health (HSPH)
Collaborators: Botswana Harvard AIDS Institute Partnership, Ragon Institute of MGH, MIT and Harvard, Botswana Ministry of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 HIV
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov