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Trial · NCT02394730

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryMean Percent Change From Baseline for D-dimer (ng/mL) to the Average of Weeks 8 and 12at week 8 and week 12Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transforming the log10 difference to obtain percentage change from baseline.
SecondaryNumber of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mLat week 18Number of participants in each treatment group with plasma HIV-1 RNA \<50 copies/mL at week 18
SecondaryMean Change From Baseline to Week 12 in CD4+ Cell Countsat week 12Mean of week 12 CD4+ cell count minus mean of week 0 CD4+ cell count
SecondaryMean Change From Baseline to Week 12 in CD8+ Cell Countsat week 12Mean of week 12 CD8+ cell count minus mean of week 0 CD4+ cell count
SecondaryNumber of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12week 12Number of patients in each treatment group with d-dimer \<165ng/mL at week 12
SecondaryNumber of Patients in Each Treatment Group With D-dimer > or Equal to 165ng/mL at Week 18week 18Number of patients in each treatment group with d-dimer \> or equal to 165ng/mL at week 18
SecondaryMean Change From Baseline in log10 D-Dimerat week 18Differences between treatment groups in mean change from week 0 log10 d-dimer to week 18
SecondaryMean Change From Baseline in log10 Hs-CRP at Week 18at week 18Differences between treatment groups in mean change from baseline log10 hs-CRP to week 18. ie Week 18 log10 hs-CRP minus week 0 log10 hs-CRP
SecondaryPercent Change From Baseline Hs-CRP (ug/mL) to the Average of Week 8 and Week 12week 8 and 12Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transformed the log10 difference to obtain percentage change from baseline.
SecondaryMean Percent Change From Baseline IL-6 (pg/mL) to the Average of Week 8 and Week 12at week 8 and week 12Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transformed the log10 difference to obtain percentage change from baseline.
SecondaryDifferences Between Treatment Groups in Mean Change From Baseline log10 IL-6at week 18Differences between treatment groups in mean change from baseline log10 IL-6 at week 18
SecondaryTotal Number of Participants With BARC Type 1, 2, 3, 4, or 5 Bleeding Episodesat week 18
Bleeding Academic Research Consortium (BARC) Definitions for Bleeding Events Type 1 -bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional Type 2 - overt, actionable sign of haemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation Type 3- Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) Type 4 - Coronary Artery Bypass Graft procedure-related bleeding Type 5 -
SecondaryTotal Number of Participants With Any SAE Between Baseline and Week 18week 18Total number of participants with any SAE between baseline and week 18
SecondaryTotal Number of Participants With Any AE Between Baseline to Week 18week 18Total number of participants with any AE between week 0 to week 18
SecondaryChanges From Baseline in Renal Function Measured by the CKD-EPI Estimate of Creatinine Clearance at Week 12at week 12Changes from baseline in renal function measured by the CKD-EPI estimate of creatinine clearance at week 12

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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