Completed

Kidney and Liver Transplantation in People With HIV

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

HIV Infections

+ Kidney Disease
+ Liver Disease
Over 12 Months
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2003

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: January 17, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleSolid Organ Transplantation in HIV: Multi-Site Study 
Principal SponsorUniversity of California, San Francisco
Last updated: January 17, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
275 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

What happens to patients' samples
Samples are kept, but they cannot be used to extract DNA. These might include materials like plasma or tissue that has been preserved in a way that damages DNA.

Other Options for Sample Use
Samples With DNA
: Samples are kept and may be used for genetic research.

None Retained
: No samples are kept after the study.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 MonthsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Kidney Disease
Liver Disease
Criteria

Inclusion Criteria for All Participants: * 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 * 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. Exclusion Criteria for All Participants: * Pregnancy * Significant wasting or weight loss


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 21 locations
Suspended
Cedar-Sinai HospitalLos Angeles, United StatesSee the location
Suspended
University of California, San FranciscoSan Francisco, United States
Suspended
Georgetown UniversityWashington, United States
Suspended
Washington Hospital CenterWashington, United States

Completed21 Study Centers