Study Summary
This trial will test if an HIV-infected donor liver is safe for transplant.
Eligible Conditions
- HIV (Human Immunodeficiency Virus)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 39 Secondary · Reporting Duration: 4 years post-transplant
1 year post-transplant
Average graft function as assessed by alanine aminotransferase (ALT)
Average graft function as assessed by aspartate aminotransferase (AST)
Graft function as assessed by Mean calculated Model for End Stage Liver Disease (MELD) score
1 years post-transplant
Average hemoglobin a1c among participants at 1 year
12 weeks HCV treatment
Hepatitis C (HCV) sustained viral response post-transplant
2 years post-transplant
Average hemoglobin a1c among participants at 2 years
3 years post-transplant
Average Graft function as assessed by ALT
Average graft function as assessed by bilirubin
Average hemoglobin a1c among participants at 3 years
Graft function as assessed by liver stiffness
4 years post-transplant
Average graft function as assessed by ALT
Average graft function as assessed by AST
Average graft function as assessed by Bilirubin
Average hemoglobin a1c among participants at 4 years
Graft function as assessed by AST to Platelet Ratio (APRI) index
Graft function as assessed by Fibrosis-4 index
Graft function as assessed by Mean calculated MELD score
Metabolic Outcome as assessed by Body mass index (BMI)
Year 4
Time to Pre-transplant mortality
Year 4
Graft Failure as assessed by Time to first occurrence of mortality or re-transplant or return to maintenance dialysis
Time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection as a composite measure
Year 4
Trajectory of recipient Cluster of Differentiation (CD4) count over time
Year 3
Graft function as assessed by incidence of fibrosis
Number of Non-alcoholic fatty liver (NAFL)
Number of steatohepatitis (NASH)
Year 4
Number of HIV breakthroughs
Number of X4 tropic virus breakthroughs
Number of opportunistic infections
Number of viral-related malignancies
Time to first occurrence of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness as a composite measure
Trajectory of recipient plasma HIV RNA over time
Year 1
Number of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies
Year 1
Number of surgical complications
Number of vascular complications
Month 6
6-month acute kidney rejection in simultaneous liver/kidney transplant recipients
Year 1
1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only
1-year acute liver rejection
Year 2
2-year acute liver rejection
Year 3
3-year acute liver rejection
Number of graft rejections in liver transplant
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
HIVD-/R+
1 of 3
HIVD-/R+ (observational)
1 of 3
HIV D+/R+
1 of 3
Active Control
Experimental Treatment
80 Total Participants · 3 Treatment Groups
Primary Treatment: HIVD+/R+ · No Placebo Group · N/A
HIV D+/R+
Other
Experimental Group · 1 Intervention: HIVD+/R+ · Intervention Types: OtherHIVD-/R+NoIntervention Group · 1 Intervention: HIVD-/R+ · Intervention Types:
HIVD-/R+ (observational)NoIntervention Group · 1 Intervention: HIVD-/R+ (observational) · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years post-transplant
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,093 Previous Clinical Trials
31,767,649 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,172 Previous Clinical Trials
4,939,856 Total Patients Enrolled
Christine Durand, MDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
516 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 14 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are not losing too much weight due to HIV disease (your body mass index is above 21).
If you need a liver and kidney transplant at the same time, you can participate if you meet the requirements for both organs.
References
- Werbel, William A, Diane M Brown, Oyinkansola T Kusemiju, Brianna L Doby, Shanti M Seaman, Andrew D Redd, Yolanda Eby, et al.. 2021. “National Landscape of Human Immunodeficiency Virus–positive Deceased Organ Donors in the United States”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciab743.
- Werbel, William A, Diane M Brown, Oyinkansola T Kusemiju, Brianna L Doby, Shanti M Seaman, Andrew D Redd, Yolanda Eby, et al.. 2021. “National Landscape of Human Immunodeficiency Virus–positive Deceased Organ Donors in the United States”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciab743.
- 2019. "HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03734393.
Frequently Asked Questions
How many participants are currently benefitting from this trial?
"This study requires 80 compliant participants, and individuals may enroll from either Weill Cornell Medical College in New York or the University of Cincinnati in Ohio." - Anonymous Online Contributor
Unverified Answer
Is enrollment for this experiment currently available to participants?
"Clinicaltrials.gov notes that this research trial is presently seeking candidates, with the original post date on April 1st 2019 and the most recent update being recorded May 4th 2022." - Anonymous Online Contributor
Unverified Answer
How many health care facilities are actively conducting this trial?
"In addition to Weill Cornell Medical College in New York, University of Cincinnati in Ohio, and the University of Miami in Florida, this trial is also recruiting participants at 24 other sites." - Anonymous Online Contributor
Unverified Answer