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HIV InfectionsNCT00074386

Kidney and Liver Transplantation in People With HIV

An observational study of HIV Infections and Kidney Disease, run by University of California, San Francisco at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With improved anti-HIV drug therapy, HIV infected patients are now living longer. These patients are at risk for liver and kidney failure and may need organ transplants. However, little is know about the safety and effectiveness of organ transplants in patients with HIV. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
HIV Infections, Kidney Disease, Liver Disease
How many people
275 participants
Where
21 sitesUnited States
Study dates
Oct 2003to Aug 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: HIV-positive patients who undergo kidney or liver transplantation.

Who may be able to join

  • HIV infection
  • Undetectable HIV viral load
  • Meet all eligibility requirements for a transplant (same requirements that HIV uninfected patients must meet)
  • Willing to take medication to prevent certain infections
  • Willing to undergo frequent monitoring, including liver biopsies, and treatment, if participant has hepatitis B or C virus infection
  • Willing to submit laboratory test results within 7 days of blood draw
Show all 12Show fewer
  • Willing to notify the transplant team before changing any medications
  • If participant has a history of HIV-related cancers or opportunistic infections, some additional eligibility criteria must be met.
  • Inclusion Criteria for Patients Undergoing Kidney Transplant:
  • CD4 count greater than 200 cells/mm3. CD4 count requirement for children will be based on child's age. Participant cannot have used the drugs IL-2 or GM-CSF in order to increase the CD4 count in the 6 months prior to transplant.
  • Inclusion Criteria for Patients Undergoing Liver Transplant:
  • CD4 count greater than 100 cells/mm3. CD4 count requirement for children will be based on child's age. Some participants with certain HIV-related diseases must have a CD4 count that is greater than 200 cells/ml for the 6 months prior to study entry.

Who cannot join

  • Pregnancy
  • Significant wasting or weight loss

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22908-0265

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • The University Hospital, Cincinnati

    Cincinnati, Ohio, 45219-2316

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Cedar-Sinai Hospital

    Los Angeles, California, 90035

  • University of Miami, Jackson Memorial Medical Center

    Miami, Florida, 33136

  • Tulane University

    New Orleans, Louisiana, 70112

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • Columbia Presbyterian Hospital

    New York, New York, 10032

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh, Thomas E. Starzl Institute

    Pittsburgh, Pennsylvania, 15213-2582

  • University of California, San Francisco

    San Francisco, California, 94105

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010-2975

Other trials in United States

About this study

Official title: Solid Organ Transplantation in HIV: Multi-Site Study

With improved anti-HIV drug therapy, HIV infected patients are now living longer. These patients are at risk for liver and kidney failure and may need organ transplants. However, little is know about the safety and effectiveness of organ transplants in patients with HIV. This study will evaluate organ transplantation in HIV infected patients undergoing liver and kidney transplants.

Read the detailed description

HIV infected people are at significant risk for end stage organ disease. Prior to the advent of highly active antiretroviral therapy (HAART), these people were often not considered transplant candidates based on concern about potential adverse effects of immunosuppressive drugs on HIV disease progression. However, with the use of HAART, HIV infected people have experienced significant improvements in morbidity and mortality. HIV infected people with end stage kidney and liver disease are now potential candidates for transplantation, yet patients and clinicians lack the necessary data to determine the safety and efficacy of transplantation and immunosuppression in this group. This lack of conclusive data has led to continued denial of care by many transplant centers and third party payers, resulting in frustration and confusion for both patients and their health care providers.

This study will evaluate the safety and efficacy of solid organ transplantation in people with HIV infection by following a prospective, multi-center cohort of HIV infected people who undergo kidney or liver transplantation. The long-term goals are: 1) to provide patients and clinicians with information regarding the HIV-specific risks of transplantation; 2) to provide clinicians with information necessary to manage immunosuppressive and HAART medications together; and 3) to understand underlying basic science mechanisms that explain patient outcomes so that clinical management can be adjusted to improve outcomes.

Approximately 150 kidney and 125 liver transplant patients will be enrolled in this study over a 3-year period at medical research centers throughout the United States. Participants will be enrolled in the study for five years from the day of the transplant.

Keywords
HIV, Transplant, Liver, Kidney, Organ, Treatment Experienced, Kidney Transplant, Liver Transplant
Medical subject headings
HIV Infections, Kidney Diseases, Liver Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject survival

    Measured: 5 years

  2. graft survival

    Measured: 5 years

Secondary outcomes (5)

  1. Opportunistic complications

    Measured: 5 years

  2. CD4+ T cell counts and HIV-1 RNA levels

    Measured: 5 years

  3. viral markers and host-response (CFC and ELISPOT) to viral co-pathogens, including HBV, HCV,CMV, EBV, HHV-6, HHV-8, and HPV

    Measured: 5 years

  4. rejection rates and markers of alloresponse

    Measured: 5 years

  5. pharmacokinetic interactions between immunosuppressive agents and antiretrovirals

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00074386
Sponsor's protocol ID
1U01AI052748
Other IDs
1U01AI052748
Status last verified
Jan 2014
First submitted
11 Dec 2003
Last updated
17 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Terrault NA, Roland ME, Schiano T, Dove L, Wong MT, Poordad F, Ragni MV, Barin B, Simon D, Olthoff KM, Johnson L, Stosor V, Jayaweera D, Fung J, Sherman KE, Subramanian A, Millis JM, Slakey D, Berg CL, Carlson L, Ferrell L, Stablein DM, Odim J, Fox L, Stock PG; Solid Organ Transplantation in HIV: Multi-Site Study Investigators. Outcomes of liver transplant recipients with hepatitis C and human immunodeficiency virus coinfection. Liver Transpl. 2012 Jun;18(6):716-26. doi: 10.1002/lt.23411.

    PubMed 22328294

  • Carter JT, Melcher ML, Carlson LL, Roland ME, Stock PG. Thymoglobulin-associated Cd4+ T-cell depletion and infection risk in HIV-infected renal transplant recipients. Am J Transplant. 2006 Apr;6(4):753-60. doi: 10.1111/j.1600-6143.2006.01238.x.

    PubMed 16539632

  • Frassetto L, Baluom M, Jacobsen W, Christians U, Roland ME, Stock PG, Carlson L, Benet LZ. Cyclosporine pharmacokinetics and dosing modifications in human immunodeficiency virus-infected liver and kidney transplant recipients. Transplantation. 2005 Jul 15;80(1):13-7. doi: 10.1097/01.tp.0000165111.09687.4e.

    PubMed 16003227

  • Roland ME, Carlson LL, Frassetto LA, Stock PG. Solid organ transplantation: referral, management, and outcomes in HIV-infected patients. AIDS Read. 2006 Dec;16(12):664-8, 675-8.

    PubMed 17195325

  • Roland ME, Stock PG. Liver transplantation in HIV-infected recipients. Semin Liver Dis. 2006 Aug;26(3):273-84. doi: 10.1055/s-2006-947297.

    PubMed 16850377

  • Roland ME, Stock PG. Solid organ transplantation is a reality for patients with HIV infection. Curr HIV/AIDS Rep. 2006 Sep;3(3):132-8. doi: 10.1007/BF02696657.

    PubMed 16970840

  • Terrault NA, Carter JT, Carlson L, Roland ME, Stock PG. Outcome of patients with hepatitis B virus and human immunodeficiency virus infections referred for liver transplantation. Liver Transpl. 2006 May;12(5):801-7. doi: 10.1002/lt.20776.

    PubMed 16628690

  • Bihl FK, Loggi E, Chisholm JV 3rd, Hewitt HS, Henry LM, Linde C, Suscovich TJ, Wong JT, Frahm N, Andreone P, Brander C. Simultaneous assessment of cytotoxic T lymphocyte responses against multiple viral infections by combined usage of optimal epitope matrices, anti- CD3 mAb T-cell expansion and "RecycleSpot". J Transl Med. 2005 May 11;3(1):20. doi: 10.1186/1479-5876-3-20.

    PubMed 15888204

  • Frassetto LA, Browne M, Cheng A, Wolfe AR, Roland ME, Stock PG, Carlson L, Benet LZ. Immunosuppressant pharmacokinetics and dosing modifications in HIV-1 infected liver and kidney transplant recipients. Am J Transplant. 2007 Dec;7(12):2816-20. doi: 10.1111/j.1600-6143.2007.02007.x. Epub 2007 Oct 19.

    PubMed 17949460

  • Stock PG, Roland ME. Evolving clinical strategies for transplantation in the HIV-positive recipient. Transplantation. 2007 Sep 15;84(5):563-71. doi: 10.1097/01.tp.0000279190.96029.77.

    PubMed 17876267

  • Frassetto LA, Tan-Tam C, Stock PG. Renal transplantation in patients with HIV. Nat Rev Nephrol. 2009 Oct;5(10):582-9. doi: 10.1038/nrneph.2009.140.

    PubMed 19776780

  • Subramanian A, Sulkowski M, Barin B, Stablein D, Curry M, Nissen N, Dove L, Roland M, Florman S, Blumberg E, Stosor V, Jayaweera DT, Huprikar S, Fung J, Pruett T, Stock P, Ragni M. MELD score is an important predictor of pretransplantation mortality in HIV-infected liver transplant candidates. Gastroenterology. 2010 Jan;138(1):159-64. doi: 10.1053/j.gastro.2009.09.053. Epub 2009 Sep 30.

    PubMed 19800334

  • Gasser O, Bihl F, Sanghavi S, Rinaldo C, Rowe D, Hess C, Stablein D, Roland M, Stock P, Brander C. Treatment-dependent loss of polyfunctional CD8+ T-cell responses in HIV-infected kidney transplant recipients is associated with herpesvirus reactivation. Am J Transplant. 2009 Apr;9(4):794-803. doi: 10.1111/j.1600-6143.2008.02539.x.

    PubMed 19298451

  • Coffin CS, Stock PG, Dove LM, Berg CL, Nissen NN, Curry MP, Ragni M, Regenstein FG, Sherman KE, Roland ME, Terrault NA. Virologic and clinical outcomes of hepatitis B virus infection in HIV-HBV coinfected transplant recipients. Am J Transplant. 2010 May;10(5):1268-75. doi: 10.1111/j.1600-6143.2010.03070.x. Epub 2010 Mar 19.

    PubMed 20346065

  • Tan-Tam CC, Frassetto LA, Stock PG. Liver and kidney transplantation in HIV-infected patients. AIDS Rev. 2009 Oct-Dec;11(4):190-204.

    PubMed 19940946

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Kidney Disease, run by University of California, San Francisco at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00074386, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.

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