Trial · NCT02431325
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake | Change from baseline at 6 months | The subset of participants with interpretable FDG-PET scans at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | ratio | MEAN |
| PRIMARY | Change in Intestinal Epithelial Integrity | Change from baseline at 6 months | The subset of participants with available metabolite assessments at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | log2 ratio | MEAN |
| PRIMARY | Change in Soluble CD14 Concentration | Change from baseline at 6 months | The subset of participants with soluble CD14 available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | ng/mL | MEAN |
| SECONDARY | Change in Intestinal CD4+ T-cells | Change from baseline at 6 months | The subset of participants with available biopsy samples from endoscopies at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | percentage of CD4+ T-cells | MEAN |
| SECONDARY | Change in CD14+CD86+CD40+ Monocytes | Change from baseline at 6 months | The subset of participants with peripheral blood flow cytometry data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. Two participants in the placebo group did not have interpretable data for this monocyte population. | percentage of CD14+ monocytes | MEAN |
| SECONDARY | Change in HLA-DR+CD38+ CD8+ T Cells | Change from baseline at 6 months | The subset of participants with peripheral blood flow cytometry at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | percentage of T Cells | MEAN |
| SECONDARY | Change in HLA-DR+CD38+ CD4+ T Cells | Change from baseline at 6 months | The subset of participants with peripheral blood flow cytometry at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | percentage of T Cells | MEAN |
| SECONDARY | Change in Soluble CD163 Concentration | Change from baseline at 6 months | The subset of participants with soluble CD163 data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | ng/mL | MEAN |
| SECONDARY | Change in Intestinal Fatty Acid Binding Protein Concentration | Change from baseline at 6 months | The subset of participants with I-FABP data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | pg/mL | MEDIAN |
| SECONDARY | Change in Plasma Riboflavin Concentration | Change from baseline at 6 months | The subset of participants with metabolite assessments at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | log2 ratio | MEAN |
| SECONDARY | Change in Bone Mineral Density | Change from baseline at 6 months | The subset of participants with bone density scans at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | g/cm^2 | MEAN |
| SECONDARY | Change in Plaque Volume on Cardiac Computed Tomography Angiography | Change from baseline at 6 months | The subset of participants with available cardiac CT data at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | mm^3 | MEDIAN |
| SECONDARY | Change in Hemoglobin A1c Percentage | Change from baseline at 6 months | The subset of participants with HbA1c assessed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | HbA1c, % | MEDIAN |
| SECONDARY | Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) | Change from baseline at 6 months | The subset of participants with fasting glucose and fasting insulin assessed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention and one participant in the active group that was not fasting for the study end blood draw. | index | MEAN |
| SECONDARY | Change in Visceral Adipose Tissue (VAT) Area | Change from baseline at 6 months | The subset of participants with single-slice abdominal CT scans performed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | cm^2 | MEAN |
| SECONDARY | Change in Subcutaneous Adipose Tissue (SAT) Area | Change from baseline at 6 months | The subset of participants with single-slice abdominal CT scans performed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | cm^2 | MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | Change from baseline at 6 months | The subset of participants with heights and weights measured at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | kg/m^2 | MEAN |
| SECONDARY | Change in Depressive Symptoms | Change from baseline at week 12 and at week 24 | The subset of participants with complete depression scales obtained by self-administered survey at baseline, 12 weeks, and 24 weeks, excluding one participant in the placebo group that discontinued ART during the intervention. Some participants that had depression scales at 24 weeks did not have them available at 12 weeks. | CES-D score | MEDIAN |
| SECONDARY | Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score | Change from baseline at week 24 | The subset of participants with neurocognitive testing results at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | z-score | MEAN |
| SECONDARY | Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score | Change from baseline at week 24 | The subset of participants with neurocognitive testing results at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. | z-score | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02431325/outcomes