Study Protocol for HIV Patients
About the Study
The Penn Transplant Center is participating in a study
evaluating the safety and
effectiveness of kidney and
liver transplants in a select
population of human
immunodeficiency virus (HIV)
infected individuals. The HIV
and Solid Organ Transplant
Multi-Site Study is a
cooperative effort between
17 health care centers. It is
sponsored by the University
of California at San Francisco
and supported by the National
Institute of Allergy and
Infectious Diseases/National
Institutes of Health, and
other sources.
Who is Eligible for this Study?
Participants in this study must:
- Have documented HIV infection.
- Be over the age of 18.
- Meet other special requirements if
there is a history of cancers or certain
opportunistic infections that are
common in people with HIV. Some of
these infections may exclude you from
participating in the study.
- Meet all the same transplant requirements for non-HIV patients.
- Provide informed consent.
- Take preventive medication so you will not get certain infections.
- Undergo frequent monitoring, including liver biopsies and treatment, if you have
hepatitis B or C.
- You cannot have used drugs IL-2 or GM-CSF in order to increase the
T-cell count in the six months prior
to transplant.
- Not be pregnant.
- Not be suffering from significant wasting.
Additionally, Liver Patients must also:
- Have a CD4 cell count that is greater than
100 cells per microliter at any time in the
previous 16 weeks. If you have a history
of certain HIV-related diseases, you must
have a T-cell count that is greater than
200 cells per microliter at any time in the
previous 16 weeks.
- Submit laboratory test results within
seven days of draw and be willing to
notify someone on the transplant team,
such as the nurse coordinator, before
changing any medications.
- If you are on chronic antiretroviral therapy,
you must have an undetectable HIV viral
load. Exceptions may be made by the local
research team if they think your viral load
will likely be reduced to undetectable
levels after the transplant.
Procedures Required Prior to Transplantation
The following tests are required to determine
if you are qualified for this study:
- Pneumovax or confirmation of receiving
pneumovax within the past five years.
-
PPD test (purified protein derivative;
tuberculin skin test) within 12 months of
transplant.
-
Hepatitis A vaccine series or confirmation
of positive antibody status.
-
Hepatitis B vaccine or confirmation of
positive surface antibody or core antibody
status. If isolated core antibody positive,
will need HBV (hepatitis B virus) DNA.
-
Cervical pap smear for all sexually active
females within six months of transplant.
- Labs: G6PD, toxoplasmosis antibody.
EBV, RPR, HCV.
- CD4+ T-cell count.
- HIV-1 RNA.
These tests may be done at the Hospital of
the University of Pennsylvania or by your
primary care provider. The test results help
the study team determine if you can
participate in this study. Additional testing
may be required based on the findings of the
initial evaluation.
Cost of the Transplant
The study does not cover the cost of the
transplant or the required testing. Patients
will need to provide payment information or
arrange for coverage from their insurance or
third-party payer.
When to Call for an Evaluation
It is not always clear when HIV-positive
patients should be referred for kidney or liver
transplantation. Some patients wait until it is
too late to be evaluated for a transplant, and
some seek evaluation as soon as a kidney or
liver problem is discovered. In general,
patients with liver disease should start
referral and work-up for liver transplantation
when they first develop liver disease
symptoms. Patients on hemodialysis or
continuous ambulatory peritoneal dialysis
(CAPD) should be evaluated for kidney
transplant. Patients with questions or
wanting more information about considering
evaluation can contact the Penn Transplant
Center.
Waiting for Your Transplant
Individuals accepted into the study are
placed on a waiting list. Being accepted
into the study does not guarantee an organ
transplant. Study participants need to be
tested every three months while waiting to be
transplanted. Eligibility at the time of organ
availability will be determined based on the
most recent lab results, which cannot be
more than 12 weeks prior to the transplant.
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