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Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
Phase 2 trial testing Maraviroc in HIV Infections in 97 participants. Completed in 10 May 2022.
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 97 |
| Start date | 1 January 2017 |
| Primary completion | 10 May 2022 |
| Estimated completion | 10 May 2022 |
| Sites | 10 locations across United States |
National Institute of Allergy and Infectious Diseases (NIAID)
18 and older, any sex, with HIV Infections or Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary efficacy endpoint is the 52-week GFR as measured by iohexol clearance
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 37.0 | 30.1 – 43.9 |
| Arm 2: Placebo | 40.1 | 26.9 – 53.3 |
The primary safety endpoint will be the incidence of graft loss and toxicities ≥ Grade 3 and/or permanent treatment discontinuation within the first 52 weeks post-transplant
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 0.84 | 0.72 – 0.93 |
| Arm 2: Placebo | 0.85 | 0.74 – 0.94 |
Based on the formalin-fixed paraffin-embedded (FFPE) kidney biopsy sample. CD45 RNA In Situ Hybridization was performed, and the CD45 gene expression count is calculated by counting the "spots" (the RNA signal) in QuPath and then dividing the number of spots by biopsy tissue area in mm².
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 49.4 | 12.3 – 129.0 |
| Arm 2: Placebo | 50.9 | 16.2 – 518.0 |
Mean CD45 quantitative immunohistochemistry (IHC) based on FFPE sample
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 144.7 | 84.5 – 294.0 |
| Arm 2: Placebo | 77.5 | 15.0 – 285.9 |
Tissue Common Rejection Module (tCRM) score using the 11-gene tCRM module on FFPE biopsy shaves at 26 weeks. The score measures the average (geometric mean) gene expression level of CRM genes (BASP1, CD6, CXCL10, CXCL9, INPP5D, ISG20, LCK, NKG7, PSMB9, RUNX3, TAP1) in kidney tissue. Possible range (min-max) for the tCRM score is 0.01 - 15.0, with higher values representing worse outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 1.83 | 1.09 – 3.36 |
| Arm 2: Placebo | 1.67 | 1.14 – 2.16 |
Urine Common Rejection Module (uCRM) score using the 11-gene uCRM module on urine cell pellets at week 26. The score measures the average (geometric mean) gene expression level of CRM genes (BASP1, CD6, CXCL10, CXCL9, INPP5D, ISG20, LCK, NKG7, PSMB9, RUNX3, TAP1) in urine sediment. Possible range (min-max) for the uCRM score is 0.01 - 15.0, with higher values representing worse outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 0.48 | 0.23 – 1.08 |
| Arm 2: Placebo | 0.42 | 0.20 – 0.87 |
Urine Common Rejection Module (uCRM) score using the 11-gene uCRM module on urine cell pellets at week 52. The score measures the average (geometric mean) gene expression level of CRM genes (BASP1, CD6, CXCL10, CXCL9, INPP5D, ISG20, LCK, NKG7, PSMB9, RUNX3, TAP1) in urine sediment. Possible range (min-max) for the uCRM score is 0.01 - 15.0, with higher values representing worse outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 0.40 | 0.12 – 0.85 |
| Arm 2: Placebo | 0.25 | 0.16 – 0.64 |
Measured by Chronic Kidney Disease Epidemiology collaboration equation (CKD-EPI) Creatinine equation
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 0.45 | 0.33 – 0.63 |
| Arm 2: Placebo | 0.73 | 0.60 – 0.89 |
Proportion of participants with defined CKD stage 4 or 5 at week 52 post-transplant. CKD Stage 4 or 5 is defined as a glomerular filtration rate (GFR) of \<30 mL/min.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 0.07 | 0.02 – 0.20 |
| Arm 2: Placebo | 0.14 | 0.06 – 0.31 |
Mean eGFR at Week 52 calculated by CKD-EPI creatinine equation
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 59.2 | 53.2 – 65.2 |
| Arm 2: Placebo | 49.3 | 43.5 – 55.1 |
The slope of eGFR over time in Year 1, calculated by CKD-EPI Creatinine equation. Slope is computed via the repeated measures analysis, covering the study time points of weeks 13, 26, 39 and 52. The estimated average slope (and corresponding 95% confidence interval) is provided for incremental progression from one time point to the next (i.e., the displayed slope shows the extent of increase (positive) or decrease (negative) in eGFR level per every time point (13 weeks) elapsed.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | -0.1 | -1.6 – 1.5 |
| Arm 2: Placebo | -0.5 | -2.2 – 1.2 |
HIV DNA in peripheral blood CD4+ T cells at Week 52. The standard ACTG type extraction protocol was used to extract DNA from PBMC. The readout was copies of cellular HIV-1 DNA per million PBMC. Subsequently, the outcome measure/value was obtained by multiplying the readout by the participant's CD4 percentage level at that time point, to obtain the measure of copies of HIV-1 DNA per million peripheral blood CD4+ T cells
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Maraviroc (MVC) | 22.2 | 4.1 – 68.4 |
| Arm 2: Placebo | 43.9 | 12.6 – 89.4 |
Time frame: Adverse events were collected during the study follow-up period of up to ~ 3 years post-transplant. Adverse events will be collected from the time of transplant until a participant completes study participation or until 30 days after he/she prematurely withdraws (without withdrawing consent) or is withdrawn from the study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1: Maraviroc (MVC) | Arm 2: Placebo |
|---|---|---|---|
| COVID-19 | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Transplant rejection | Immune system disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Pyrexia | General disorders | — | — |
| Pyelonephritis | Infections and infestations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Oesophagitis | Gastrointestinal disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Bacteraemia | Infections and infestations | — | — |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | — | — |
| Delayed graft function | Injury, poisoning and procedural complications | — | — |
| Haemoglobin decreased | Investigations | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Reaction | System | Arm 1: Maraviroc (MVC) | Arm 2: Placebo |
|---|---|---|---|
| Haemoglobin decreased | Investigations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Blood glucose increased | Investigations | — | — |
| Glomerular filtration rate abnormal | Investigations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Transplant rejection | Immune system disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — |
| Pyelonephritis | Infections and infestations | — | — |
| Haematuria | Renal and urinary disorders | — | — |
Most-reported serious reactions: COVID-19, Urinary tract infection, Hyperglycaemia, Transplant rejection, Acute kidney injury, COVID-19 pneumonia, Pneumonia, Pyrexia.
Data from ClinicalTrials.gov NCT02741323 adverse events section.
Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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