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Trial · NCT07908446

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryProportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 24, as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot AlgorithmWeek 24
SecondaryProportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 using the US FDA-defined snapshot algorithmWeek 48
SecondaryProportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the US FDA-Defined Snapshot AlgorithmWeek 24
SecondaryProportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the US FDA-Defined Snapshot AlgorithmWeek 48
SecondaryChange From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24Baseline, Week 24
SecondaryChange From Baseline in CD4 Cell Count at Week 48Baseline, Week 48
SecondaryPercentage of Participants Experiencing Treatment-Emergent Grade 3 or 4 Adverse Events (AEs)First dose date up to Week 48 plus 60 days
SecondaryPercentage of Participants Experiencing Treatment-Emergent Serious Adverse events (SAEs)First dose date up to Week 48 plus 60 days
SecondaryPercentage of Participants Experiencing Treatment-Emergent AEs Leading to Discontinuation of Study Drug Through Week 48Up to week 48
Secondary
Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 24
Baseline, Week 24
The QUEST-HIV-T is a patient-reported outcome (PRO) measure that evaluates experience and satisfaction in a clinical study for HIV. The measure consists of 16-item that is intended to be completed by PWH during an active treatment period using a recall period of "the past 7 days." The QUEST-HIV-T utilizes 5-point verbal descriptor scales (Not at all-Extremely, Very satisfied-Very dissatisfied).
Secondary
Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 48
Baseline, Week 48
SecondaryProportion of Participants Reporting a Preference for BIC/LEN FDC Compared with Previous SBR, as Assessed by the HIV-Treatment Preference Questionnaire (HIV-TPQ) at Week 48Week 48
The HIV-Treatment Preference Questionnaire (HIV-TPQ) is a PRO measure designed to evaluate participants' preference between treatment received prior to the study entry and the clinical study intervention. The HIV-TPQ assesses preference across multiple treatment attributes. The overall preference item uses a 3-point categorical response scale (Treatment before the study, Study treatment, No preference). All remaining items use a 5-point verbal descriptor scale (Very much prefer treatment before the study-Very much prefer study intervention).

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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