Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients (NCT02741323) | Clinical Trial Compass
CompletedPhase 2
Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
United States97 participantsStarted 2017-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is able to understand and provide informed consent.
* Documented HIV infection (by any licensed enzyme-linked immunosorbent assay \[ELISA\] and confirmation by Western Blot, positive HIV antibody (ab) indirect fluorescent antibody (IFA), or documented history of detectable HIV-1 RNA).
* Participant is 18 years of age or older.
* CD4+ T-cell count greater than or equal to 200/µL at any time in the 26 weeks prior to enrollment.
* Most recent HIV-1 RNA less than 50 copies RNA/mL. Eligibility at the time of enrollment will be determined based on the most recent HIV-1 RNA, not more than 26 weeks prior to enrollment. Subjects who require a switch in combination antiretroviral therapy (cART) regimen to become study eligible must also have an eligible HIV-1 RNA result post change in cART.
* Participant meets standard listing criteria for placement on transplant waiting list.
* For participants with an HIV+ deceased donor:
* No active opportunistic infections.
* Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant.
* Must be enrolled in an Institutional Review Board (IRB) approved research protocol that fulfills the requirements of the DHHA Hope Act Policy (see the protocol for more information).
* HIV+ deceased donor must have no evidence of invasive opportunistic complications of HIV infection, and must have a pre-implant biopsy.
* Antiretroviral (ARV) Use: …
What they're measuring
1
Mean Glomerular Filtration Rate by Iohexol Clearance at Week 52
Timeframe: Measured at Week 52 Post-transplant
2
Cumulative Incidence of Graft Loss, Toxicities ≥ Grade 3 Per the DAIDS Toxicity Table and/or Permanent Treatment Discontinuation
Timeframe: Measured through Week 52 Post-transplant
Trial details
NCT IDNCT02741323
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)