Trial · NCT07384624
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I primary outcome: Fold change in cell-associated HIV-RNA | At time points 6 and 24 hours after treatment, compared to baseline | The fold change in cell-associated HIV-RNA within and between the study arms |
| Primary | Phase II primary outcome: Log transformed HIV-DNA | At time point 4 weeks compared to baseline | The change in log transformed HIV-DNA within the treatment group. Measured using IPDA and SQuHIVLa |
| Secondary | Phase I & II: Clinical safety and tolerability of the LRA drug combination. | Phase I: 1 week Phase II: 5 weeks | The number and severity of clinical and biochemical adverse events assessed using Common Terminology Criteria for Adverse Events version 6 |
| Secondary | Phase I: Participant preference on the latency reversing agent (LRA) combinations. | At 0 hours, 24 hours and 7 days | Participant preference for LRA combinations, quantitatively assessed using a pill diary with Likert scales 1-5 (higher scores meaning better outcome) |
| Secondary | Phase I: Participant quality of life during combination LRA treatment | Baseline, and at timepoint 7 days | To evaluate qualitative patient reported outcomes of quality of life assessed by semi-structured interviews |
| Secondary | Phase I: Plasma HIV-RNA kinetics during interventional treatment | At time points 6 hours, 24 hours and 7 days compared to baseline | Change in plasma HIV-RNA between and within arms |
| Secondary | Phase I: Change of the functionality of immune cells | At 7 days, compared to baseline | The change of the functionality of innate and adaptive immune cell subpopulations, specifically total T cells and HIV specific CD4+ and CD8+ T cells as well as HIV specific antibody profiles, between and within the groups |
| Secondary | Phase I: Change of the phenotype of immune cells | At 7 days, compared to baseline | The change of the phenotype of innate and adaptive immune cell subpopulations, specifically total T cells and HIV specific CD4+ and CD8+ T cells as well as HIV specific antibody profiles, between and within the groups |
| Secondary | Phase I: Pharmacokinetics of LRA compounds | At time points 2 hours, 6 hours, 24 hours and 7 days compared to baseline | Plasmaconcentrations Cmax will be measured using validated methods and related to the primary endpoint |
| Secondary | Phase I: Pharmacokinetics of LRA compounds | At time points 2 hours, 6 hours, 24 hours and 7 days compared to baseline | Plasmaconcentrations Cthrough will be measured using validated methods and related to the primary endpoint |
| Secondary | Phase I: Drug plasma levels of ART | At time points 0 hours, 6 hours, 24 hours and 7 days | Plasma concentrations Cmax of ART (antiretroviral therapy) will be measured using validated methods and related to LRA compounds |
| Secondary | Phase I: Drug plasma levels of ART | At baseline and at time points 6 hours, 24 hours and 7 days | Description: Plasma concentrations Cthrough of ART (antiretroviral therapy) will be measured using validated methods and related to LRA compounds |
| Secondary | Phase I: Ex vivo/ In vivo correlation of reservoir reactivation | From time points baseline to 24 hours | The correlation between ex vivo and in vivo fold change in cell-associated HIV-RNA |
| Secondary | Phase II: Participant quality of life during LRA combination treatment. | At baseline and timepoint 4 weeks | To evaluate qualitative patient reported outcomes of quality of life assessed by semi-structured interviews |
| Secondary | Phase II: Plasma HIV-RNA kinetics during interventional treatment | At timepoints 24 hours, 1 week, 2 weeks, 3 weeks and 4 weeks compared to baseline | Change in plasma HIV-RNA absolute copies/mL within groups |
| Secondary | Phase II: functionality of innate and adaptive immune cells | At time points 1 week, 2 weeks, 3 weeks and 4 weeks compared to baseline | The change of the functionality of innate and adaptive immune cell subpopulations, specifically total T cells and HIV specific CD4+ and CD8+ T cells as well as HIV specific antibody profiles, between and within the groups |
| Secondary | Phase II: Phenotype of innate and adaptive immune cells | At time points 1 week, 2 weeks, 3 weeks and 4 weeks compared to baseline | The change of the phenotype of innate and adaptive immune cell subpopulations, specifically total T cells and HIV specific CD4+ and CD8+ T cells as well as HIV specific antibody |
| Secondary | Phase II: Pharmacokinetics LRA compounds | At time points 1 week, 2 weeks, 3 weeks and 4 weeks compared to baseline | Plasmaconcentrations Cmax will be measured using validated methods and related to the primary endpoint |
| Secondary | Phase II: Pharmacokinetics of LRA compounds | At time points 1week, 2 weeks, 3 weeks and 4 weeks compared to baseline | Plasmaconcentrations Cthrough will be measured using validated methods and related to the primary endpoint |
| Secondary | Phase II: Drug plasma levels of ART | At time points 1 week, 2 weeks, 3 weeks and 4 weeks | Plasma concentrations Cmax of ART will be measured using validated methods. The pharmacokinetic profiles ART will be assessed in relation to the primary endpoint and LRA compounds |
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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