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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

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.

Details

MVC is a CCR5 inhibitor that may have a positive role in modulating the immune response following transplantation. The purpose of this study is to evaluate the safety and tolerability of MVC in HIV-infected adults in need of a kidney transplant. The study will also evaluate whether using both immunosuppressant drugs and MVC will improve kidney function after a kidney transplant.

This study will enroll HIV-infected adults on combination antiretroviral therapy (cART) who need a kidney transplant. At the time of their kidney transplant, study participants will be randomly assigned to receive either MVC or placebo as an addition to their cART regimen. (MVC or placebo will be provided by the study. However, the HIV medicines in their cART regimens will not be provided by the study.) Participants will receive MVC or placebo throughout their participation in the study, which will be 1 to 3 years depending on when they enroll in the study.

Study visits will occur at enrollment (Day 0) and post-transplant Weeks 1, 2, 4, 8, 13, 26, 39, 52, 78, 104, 130, and 156. Study visits may include a physical examination, blood collection, lymph node collection, urine sample collection, and a kidney biopsy. During the study, participants will also be monitored closely for evidence of drug toxicities, HIV treatment failure and rejection.

Keywords

HIV Infections Maraviroc

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 16 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 16 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 at least 4 weeks 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: Participant is on stable cART regimen for at least 3 months prior to enrollment (unless changes are made due to toxicity, drug interactions,convenience or to an eligible integrase inhibitor-based regimen). Switch should not be due to virologic failure.
  • If on a non-integrase inhibitor based regimen, participant must be switched to an integrase inhibitor-based regimen based on lack of any prior drug resistance or antiretroviral-treatment failure, and be willing to remain on indefinitely unless a change is medically necessary. Participants who need to be switched must have been on a stable cART regimen for at least 3 months prior, and must be on the new integrase inhibitor-based regimen for at least 4 weeks prior to entry. Subjects who require a switch in cART regimen to become study eligible must also have an eligible HIV-1 RNA result at least 4 weeks post change in cART (and not more than 16 weeks prior to transplant).
  • If already on a stable regimen of 2 nucleoside reverse transcriptase inhibitors(NRTIs) and an integrase inhibitor, participant is willing to remain on this regimen indefinitely unless a change in regimen is medically indicated.
  • If untreated, must initiate and be willing to remain on indefinitely an antiretroviral regimen of two nucleoside reverse transcriptase inhibitors (NRTIs)and an integrase inhibitor unless a change is medically necessary.
  • No known allergy or intolerance to components of maraviroc (MVC) or its formulation.
  • No known contraindication to MCV.
  • Female participants of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test within 30 days of randomization.

You CAN'T join if...

  • Participant is currently on MVC.
  • Participant needs multi-organ transplant.
  • Participant has a live donor who is HIV+.
  • Participant is unable to switch to an integrase inhibitor-based cART regimen.
  • Participant has received immunosuppressant medication in the 6 months prior to enrollment. Note: Low dose maintenance steroids (less than or equal to 10 mg per day of prednisone, or equivalent strength steroid) will not be considered immunosuppression.
  • Opportunistic Complication History: Any history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of greater than 1 month duration, or primary central nervous system (CNS) lymphoma. Note: History of pulmonary coccidiodomycosis will be treated per local site policy regarding this infection in HIV negative transplant candidates, generally requiring a 5-year disease-free interval.
  • Participant has a history of any neoplasm except for the following: resolved kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease-free state for 2 years. History of leukemia and disease-free duration will be per site policy.
  • Substance use that in the opinion of the investigator would interfere with compliance with the study requirements.
  • Participant is pregnant or breastfeeding. Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.
  • Participant has used interleukin-2 (IL-2) or granulocyte-macrophage colony-stimulating factor (GM-CSF) in the prior six months.
  • Participant has received interferon-alpha therapy in the prior 12 weeks.
  • Use of investigational drugs within 4 weeks of enrollment.
  • Past or current medical problems or findings from medical history, physical examination, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.

Locations

  • UCLA HIVTR-CCR5 Non-Network CRS accepting new patients
    Los Angeles, California, 90024, United States

Details

Status
accepting new patients
Start Date
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT02741323
Phase
Phase 2
Lead Scientist
Peter Stock
Study Type
Interventional
Last Updated
April 1, 2017
I’m interested in this study!