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Virus Therapy
HIV D+/R+ for HIV
N/A
Waitlist Available
Led By Christine Durand, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of transplant to end of follow-up, up to 4 years
Awards & highlights
Study Summary
This trial will test if it is safe to transplant a kidney from a deceased person with HIV into another person with HIV.
Who is the study for?
This trial is for HIV+ adults over 18 who have stable health, with CD4+ T-cell counts ≥200/µL and controlled HIV viral load. They must be seeking a kidney transplant without a living donor available, agree to birth control if applicable, and commit to ongoing HIV management. Excluded are pregnant or breastfeeding individuals, those with certain neurological conditions like PML or CNS lymphoma.Check my eligibility
What is being tested?
The study tests the safety of kidney transplants from deceased donors who were also HIV positive (HIVD+) in recipients with HIV. It aims to assess major complications related to both the transplant procedure and the management of HIV post-transplant.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include typical transplant-related complications such as organ rejection or infection and any issues arising from managing two concurrent strains of HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of transplant to end of follow-up, up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of transplant to end of follow-up, up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite event, time to first death or graft failure or serious adverse event (SAE) or HIV breakthrough or opportunistic infection
Secondary outcome measures
1-year acute rejection
6-month acute rejection
Composite event, time to first
+21 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: HIV D+/R+Experimental Treatment1 Intervention
HIV-infected individuals that accept an organ from an HIV-infected deceased donor - enrollment 80
Group II: HIV D-/R+ (observational)Active Control1 Intervention
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group - enrollment 200
Group III: HIV D-/R+Active Control1 Intervention
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor -enrollment 80
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,480,972 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,493 Total Patients Enrolled
Christine Durand, MDPrincipal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
636 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are currently hosting this clinical experiment?
"A total of 29 medical centres are participating in this clinical trial, among them Emory University (Atlanta), Columbia University Medical Center (New york) and UPMC-University of Pittsburgh Medical Centre (Pittsburgh)."
Answered by AI
Are there any current openings to join this research endeavor?
"Clinicaltrials.gov indicates that this study, which began in April 2018 and was last edited on August 15th 2022, is no longer looking for participants; however, there are still 169 other medical trials actively enrolling volunteers at present."
Answered by AI
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