Expired Study
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Rockville, Maryland 20850


Purpose:

The purpose of this study is to look at how kidney transplants and anti-rejection drugs affect the course of HIV disease and how HIV disease affects the success of kidney transplants. This study will also examine whether there are drug interactions between anti-rejection and anti-HIV drugs. People with HIV are at an increased risk for kidney problems. If these problems get worse, the kidneys may stop working completely. One way to deal with this is a kidney transplant. Transplants often have not been done in HIV-infected people because the drugs needed to prevent rejection of the transplant were thought to worsen HIV disease. However, studies have shown that some anti-rejection drugs actually might slow HIV disease. This study will provide more information about kidney transplantation in people with HIV infection. It will also study whether anti-rejection drugs and anti-HIV drugs can be given together.


Study summary:

Improvements in the treatment of HIV and survival of people with HIV have resulted in increasing numbers of HIV-infected patients dying from end stage organ disease rather than AIDS-associated opportunistic infections and neoplasms. Since HIV-infected people are at significant risk for End Stage Renal Disease, kidney transplantation is increasingly sought. People with HIV usually have been excluded from consideration for solid organ transplantation out of concern about potential adverse effects of immunosuppressive drugs on HIV disease progression. However, reviews of the long-term survival of HIV-positive transplant recipients without progression to AIDS suggest that certain immunosuppressive drugs may not only protect transplant recipients from the alloimmune response, but may decrease HIV disease progression. This "proof of principle" study evaluates the reciprocal impact of kidney transplantation and HIV infection. The compatibility of immunosuppressive and antiretroviral agents is also addressed. Patients with end-stage kidney disease and HIV infection who meet both transplantation and study criteria are eligible for registration. After eligibility is determined, patients have CD4 T-cell and HIV-1 RNA assays performed every 2 months. Eligibility at the time of organ availability is determined based on the most recent CD4 T-cell count and viral load result, not more than 10 weeks prior to transplant. If eligible, patients are hospitalized for transplant and post-operative recovery. The following interventions are administered: 1. Immunosuppression, with a calcineurin inhibitor (cyclosporine or tacrolimus), mycophenolate mofetil, and steroids. 2. Rejection treatment, if required, which may include sirolimus. 3. HIV-related prophylaxis of toxoplasmosis, by Bactrim (sulfamethoxazole/trimethoprim), dapsone with pyrimethamine and leucovorin, or atovaquone with or without pyrimethamine and leucovorin; and of Mycobacterium avium complex, by azithromycin, clarithromycin, or rifabutin. 4. Transplant-related prophylaxis of cytomegalovirus and/or herpes simplex virus, by acyclovir or ganciclovir; of Epstein-Barr virus, by ganciclovir; and of candidiasis, by Mycelex troches or fluconazole. 5. HIV- and transplant-related prophylaxis of Pneumocystis carinii pneumonia (PCP), by Bactrim (sulfamethoxazole/trimethoprim), dapsone, atovaquone, or pentamidine. This is indicated in all patients for life. 6. Vaccinations with Pneumovax, hepatitis A & B vaccines (if not immune), and influenza vaccine prior to transplant. 7. Tuberculosis testing and prophylaxis, with PPD testing at screening and every 6 months; and prophylaxis following a previous or current reaction, by isoniazid and pyridoxine, rifampin and pyrazinamide, rifabutin and pyrazinamide, or rifampin alone. During the study, patients have at least 6 inpatient, 14-hour clinic visits (screening, Week 2, Week 28, Week 52, Year 2, and Year 5), in addition to regular outpatient visits. Clinical evaluations and physical examinations at each clinic visit focus on signs and symptoms suggestive of HIV disease progression, impaired allograft function, and rejection. Clinical evaluation concentrates on symptoms and examination findings of the oropharynx, respiratory, cardiac, gastrointestinal, skin, lymphatic, and nervous system. Patients are screened for markers of opportunistic, hepatitis B, and hepatitis C infections. Immunology and pharmacology testing also is performed. CD4 T-cell, HIV-1 RNA, and standard laboratory tests are performed at each outpatient and clinic visit.


Criteria:

Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have a CD4 T-cell count at or above 200/ml for the past 6 months. - Have HIV-1 RNA less than 50 copies/ml for 3 months, with or without the use of antiretroviral drugs. - Meet criteria for placement on a transplant waiting list. - Are able to provide consent. In case of a minor (if under 18 years of age), parent or guardian must consent. - Agree to use drugs to prevent PCP, herpes virus, and fungal infections as needed. - Agree to have repeated checkups if infected with the hepatitis C virus (HCV). - Agree to tell the study coordinator before changing any drugs. - Have a negative pregnancy test within 14 days of screening, if female and able to have children. All patients must use barrier methods of birth control. - Meet minimum weight limits and have not lost a large amount of weight. - Have a Karnofsky performance score of 70 or greater. Exclusion Criteria Patients will not be eligible for this study if they: - Have had any AIDS-related infection (except thrush that was treated by drugs) or tumor in the past. - Have had certain fungal infections or tuberculosis in the past. - Have had the flu or a lung infection caused by the respiratory syncytial virus in the past 30 days. - Have had any neoplasm except in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy (disease free for more than 5 years). - Are not willing to take anti-rejection drugs, anti-HIV drugs, and/or HCV checkups and treatment if needed. - Abuse drugs or alcohol. - Have advanced heart or lung disease. - Have physical abnormalities that disqualify them from getting a transplant. - Have medical conditions that, in the opinion of the investigator, would disqualify them from getting a transplant or taking anti-rejection drugs. - Are pregnant. - Have received interleukin-2 (IL-2) or granulocyte macrophage-colony stimulating factor (GM-CSF) in the past 6 months. - Have any conditions that, in the judgement of the investigators, would disqualify a patient from transplantation or immunosuppression.


Study is Available At:


Original ID:

DAIT HIVK


NCT ID:

NCT00023478


Secondary ID:


Study Acronym:


Brief Title:

Kidney Transplants in People With HIV Infection


Official Title:

Clinical, Immunologic, and Pharmacologic Consequences of Kidney Transplantation in People With HIV Infection


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter Stock, MD, PhD
Principal Investigator

Study Dates

Start Date:April 2001
Primary Completion Date:January 2007
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 8, 2013
First Received Date:September 7, 2001

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of opportunistic infections
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacokinetic interactions between immunosuppressive agents and ARV agents
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Graft survival
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Patient survival
Time Frame:Throughout study
Safety Issues:True

Study Interventions

Intervention Type:Other
Name:Standard of Care Post-transplant Immunosuppression
Intervention Type:Drug
Name:Standard of Care Anti-retroviral Regimen for HIV I

Study Arms

Study Arm Type:Experimental
Arm Name:A
Description:All study participants

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Samples and Retentions

Study Population: HIV+ Kidney transplant recipients
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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