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Trial · NCT03041012

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPlasma HIV RNA kinetics3 monthsTime to undetectable (\<20 c/mL)
PrimaryQuantification of the size of the proviral HIV reservoir1 yearCopies of total HIV-1 DNA per 10⁶ CD4+ T cells as measured by digital droplet PCR
PrimaryTime to viral rebound during ATI12 weeksDays from stopping ART to plasma HIV RNA \>5,000 on two consecutive measurements
SecondaryIncidence of treatment emerging events (Safety and tolerability)1 yearFrequence and severity of adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and suspected unexpected serious adverse reactions (SUSAR).
SecondaryQuantification of the intact proviral DNA1 yearIntact HIV-1 DNA in CD4+ T cells (copies per million cells) as measured by dd-PCR.
SecondaryQuantification of HIV mRNA and/or p24 positive cells30 days from study entryFrequency of mRNA/p24 postive per 1 million CD4+ T cells by FISH-flow
SecondaryImmune reconstitution1 yearAbsolute CD4+ and CD8+ T cell count
SecondaryAnalytic treatment interruption (ATI) study64 weeksTime to first plasma HIV RNA \>5000 c/mL
SecondaryImpact of pre-ART virus sensitivity to 3BNC117 on ATI outcomesBaseline and at viral rebound3BNC117 sensitivity determined by PhenoSense and/or HIV env sequencing
SecondaryT cell mediated HIV specific immunityFirst of 365 daysT cell immunity as determined by the HIV AIM assay
OtherPlasma cytokine and immune activation biomarker levels1 yearSoluble IL-6, sCD14, sCD163

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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