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Trial · NCT06660498

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryEfficacy of treatment, measured as the time from ART cessation until meeting ART restart criteria.From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
PrimarySafety of treatment, measured by the number of treatment-emergent adverse events (AEs) of grade 3 or higher that are probably or definitely related to the study treatment.From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondarySafety, defined as all other treatment-emerging adverse events (AEs)From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteriaAEs are graded according to severity and assessed as either not related or possibly, probably or definitely related to study treatment.
SecondaryRebound viral kinetics during the ATI, including plasma HIV-1 RNA copies/mL doubling timesFrom ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryThe proportion of participants maintaining HIV-1 RNA levels below 1,000 copies/mL at the end of the ATI.From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryThe proportion of participants who have not met ART restart criteria at the end of the ATI.From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryThe frequency of peripheral blood CD4+ T cells containing total and intact HIV-DNA while on suppressive ARTFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryHIV-specific CD4+ responsesFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryHIV-specific CD8+ T cell responsesFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryThe proportion of cells containing constitutive and inducible MS HIV-RNAFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryThe level of CA-US HIV RNA in peripheral blood CD4+ T cellsFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryNumbers of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsetsFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
SecondaryProportions of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsetsFrom enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

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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