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Trial · NCT07216794

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryChange in intact HIV-1 deoxyribonucleic acid (DNA) copies by the Intact Proviral DNA Assay (IPDA) in peripheral bloodBaseline to week 24
SecondaryAmount of ALN excreted after initial dose of ALNOver 24 hours
SecondaryPeripheral blood CD4+ cell-associated (CA) HIV-1 RNA levels (unspliced and multiply spliced species by quantitative polymerase chain reaction [qPCR])At Baseline and Weeks 12, 24 and 32
SecondaryNumber of plasma HIV-1 RNA copies [by single copy assay (SCA)]At Baseline and Weeks 12, 24 and 32
SecondaryHIV RNA in the GI tract (RNA scope and spatial immunophenotyping in sigmoidoscopy samples)Pre-intervention and Weeks 22-24
SecondaryNumber of intact HIV-1 DNA copies by the IPDA in peripheral bloodWeeks 2, 12, and 32
SecondaryHIV DNA in the GI CD4+ and Vdelta1 (Vd1) T cells (DNA scope in sigmoidoscopy samples)Pre-intervention and Weeks 22-24
SecondaryPeripheral blood CD4+ cell-associated (CA) HIV-1 RNA levels (unspliced and multiply spliced species by qPCR)At Baseline and Weeks 1 and 2
SecondaryNumber of plasma HIV-1 RNA copies (by SCA)At Baseline and Weeks 1 and 2
SecondaryFrequency of αβ CD8+ cells by flow cytometryPre-intervention and Weeks 1, 12, 24, and 32
SecondaryPhenotype of αβ CD8+ cells by flow cytometryPre-intervention and Weeks 1, 12, 24, and 32
SecondaryFrequency of γδ cells by flow cytometryPre-intervention and Weeks 1, 12, 24, and 32
SecondaryPhenotype of γδ cells by flow cytometryPre-intervention and Weeks 1, 12, 24, and 32
SecondaryFrequency of NK cells by flow cytometryPre-intervention and Weeks 1, 12, 24, and 32
SecondaryPhenotype of NK cells by flow cytometryPre-intervention and Weeks 1, 12, 24, and 32
SecondaryHIV-specific responses (IFN- γ and GzmB) by FluorospotPre-intervention and Weeks 1, 12, 24, and 32
SecondaryPresence of plasma markers of inflammation/activationPre-intervention and Weeks 1, 12, 24, and 32

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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