174 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
Patients are exposed to infectious agents regularly, regardless of their immunologic status. Traditionally clinicians have decided to institute prophylaxis based on epidemiologic factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method that is non-invasive, such as quantitative PCR, would be desirable to more precisely define those who would benefit from prophylaxis. Similarly, when patients develop disease and are being treated, quantitative, non-invasive techniques are needed to assess response to therapy. This project is designed to develop and test quantitative tests using blood, urine, or sputum samples.
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections. The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). Participants will be followed for one year.
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: * Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) * Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)
Background: Idiopathic CD4 lymphopenia (ICL) is a syndrome characterized by low levels of certain immune cells called CD4 T cells. The low CD4 T cells renders people with ICL prone to many types of severe infections, autoimmune diseases, and cancers. Although these infections and diseases can be treated whenever occur, there is currently no treatment that targeting the underlying deficiency of CD4 T cells can provide a definitive treatment for people with ICL. Objective: To test a new drug (NT-17) in people with ICL which can increase the number of CD4 T cells Eligibility: People aged 18 to 75 years with ICL who are also enrolled in NIH protocol 09-I-0102. Design: Participants will be screened. They will have a physical exam and blood tests. Some participants with high suspicion of central nervous system infection or history of such infections may also undergo a lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord. Participants will receive 3 doses of NT-17, each about 12 weeks apart. NT-17 is injected into the muscle of the upper arm, thigh, or buttock. They will visit the clinic 5 days before each dose and again 2 and 4 weeks after each dose. Blood will be drawn at all visits. Participants will undergo leukapheresis 3 times. Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. Some visits will include a rectal swab. Some participants may have additional tests, including a skin exam, skin biopsies, and medical imaging. Participants will have 3 follow-up visits every 3 months after they finish treatment.
Background: During a transplant, blood stem cells from one person are given to someone else. The cells grow into the different cells that make up the immune system. This can cure people with certain immunodeficiencies. But transplant has many risks and complications. Objective: To see if stem cell transplant can be successfully performed in people with primary immunodeficiency disease and cure them. Eligibility: People ages 4-69 for whom a primary immunodeficiency (PID) or Primary Immune Regulatory Disorder (PIRD), has caused significant health problems and either standard management has not worked or there are no standard management options, along with their donors Design: Donors will be screened under protocol 01-C-0129. They will donate blood or bone marrow. Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests CT or PET scans Before transplant, participants will have dental and eye exams. They will have a bone marrow biopsy. For this, a needle will be inserted through the skin into the pelvis to remove marrow. Participants will be hospitalized before their transplant. They will have a central catheter put into a vein in their chest or neck. They will get medications through the catheter to prevent complications. Participants will get stem cells through the catheter. They will stay in the hospital for at least 4 weeks. They will give blood, urine, bone marrow, and stool samples. They may need blood transfusions. They may need more scans. They will take more medications. Participants will have visits on days 30, 60, 100, 180, and 360, and 24 months after the transplant. Then they will have visits once a year for about 5 years
Background: Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause. Objective: To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects. Eligibility: Recipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments Donors: Healthy people ages 18 and older whose relative has lymphoma Design: Participants will be screened with: Physical exam Blood and urine tests Bone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow. Donors will also be screened with: X-rays Recipients will also be screened with: Lying in scanners that take pictures of the body Tumor sample Donors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm. Recipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy. Recipients will get the transplant through their catheter. Recipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months. Recipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.
Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another. Researchers think this treatment can provide a new, healthy immune system to correct T-cell problems in some people. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with T-cell problems. Eligibility: Donors: Healthy people ages 4 and older Recipients: People the same age with abnormal T-cell function causing health problems Design: All participants will be screened with: * Medical history * Physical exam * Blood, heart, and urine tests Donors will also have an electrocardiogram and chest x-ray. They may have veins tested or a pre-anesthesia test. Recipients will also have lung tests. Some participants will have scans and/or bone marrow collected by needle in the hip bones. Donors will learn about medicines and activities to avoid and repeat some screening tests. Some donors will stay in the hospital overnight and have bone marrow collected with anesthesia. Other donors will get shots for several days to stimulate cells. They will have blood removed by plastic tube (IV) in an arm vein. A machine will remove stem cells and return the rest of the blood to the other arm. Recipients will have: * More bone marrow and a small fragment of bone removed * Dental, diet, and social worker consultations * Scans * Chemotherapy and antibody therapy for 2 weeks * Catheter inserted in a chest or neck vein to receive donor stem cells * A hospital stay for several weeks with more medicines and procedures * Multiple follow-up visits...
The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into the patient, to try to give the immune system the ability to fight the infection. Adoptive T cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Background: Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or bone marrow and given to another person. Researchers think this may help people with immune system problems. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with primary immunodeficiencies. Eligibility: Donors: Healthy people ages 4 or older Recipients: People ages 4-75 with a primary immunodeficiency that may be treated with allogeneic blood or marrow transplant Design: Participants will be screened with medical history, physical exam, and blood tests. Participants will have urine tests, EKG, and chest x-ray. Donors will have: Bone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone. OR Blood collection: They will have several drug injections over 5-7 days. Blood is taken by IV in one arm, circulates through a machine to remove stem cells, and returned by IV in the other arm. Possible vein assessment or pre-anesthesia evaluation Recipients will have: Lung test, heart tests, radiology scans, CT scans, and dental exam Possible tissue biopsies or lumbar puncture Bone marrow and a small piece of bone removed by needle in the hipbone. Chemotherapy 1-2 weeks before transplant day Donor stem cell donation through a catheter put into a vein in the chest or neck Several-week hospital stay. They will take medications and may need blood transfusions and additional procedures. After discharge, recipients will: Remain near the clinic for about 3 months. They will have weekly visits and may require hospital readmission. Have multiple follow-up visits to the clinic in the first 6 months, and less frequently for at least 5 years.
The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in lymphocyte subtypes other than CD4+ and CD8+ T cells.
Background: * Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic infections or autoimmune disorders and diseases. Objectives: * To characterize the natural history with regard to CD4+ T cell count and onset of infection, malignancy, and autoimmunity. * To describe the immunological status of patients affected by ICL while providing the best possible standard therapy to eradicate opportunistic infections. * To establish the timeline of CD4 lymphocytopenia, with particular focus on defining subgroups of patients according to the decline, stabilization, or rise of CD4+ T cell counts over time. * To characterize the opportunistic infections that occur in ICL patients at microbiologic and molecular levels. * To characterize the immunophenotype and possible genetic immunodeficiency causes of ICL. * To determine whether measurable immunologic parameters correlate with the development of opportunistic infections or other comorbidities such as lymphoma in patients with ICL. * To determine whether there is any association between ICL and autoimmunity. * To determine CD4+ T cell turnover, survival, functionality, and cytokine responsiveness in ICL patients. Eligibility: * Patients 2 years of age and older with an absolute CD4 count less than 300 in children 6 years or older and adults or less than 20% of T cells in children younger than 6 on two occasions at least 6 weeks apart. * Patients with negative results of HIV testing by ELISA, Western Blot, and viral load. * Patients must not have underlying immunodeficiency conditions, be receiving cytotoxic chemotherapy (anti-cancer drugs that kill cells), or have cancer. Design: * At the initial visit to the National Institutes of Health, the following evaluations will be conducted: * Personal and family medical histories. * Physical examination, including rheumatology evaluation and other consultations as medically indicated (e.g., dermatology, pulmonology, ophthalmology, imaging studies). * Blood samples for analysis of red and white blood cell counts, liver function, immune hormones, and antibody and autoantibody levels, white blood cell growth and function, and DNA. * Urinalysis and urine pregnancy testing for female patients of childbearing age. * Evaluation and treatment of active infections as medically indicated, including biopsies, buccal swabs, pulmonary function tests, and imaging studies. * Follow-up visits will take place approximately every 12 months or more frequently if indicated, and will continue for a minimum of 4 years and a maximum of 10 years. * Evaluations at follow-up will include blood samples (i.e., CBC with differential, biochemical profile, HIV testing, etc.) and urinalysis and rheumatology consults.
This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection. People 18 years of age and older with suspected or confirmed HIV infection who live in the Washington, D.C., metropolitan area may be eligible for this study. Physician referral is required. Participants come to the NIH Clinical Center a minimum of once every 3 to 4 months for evaluation with a physical examination; blood tests for research purposes, safety, immune status and viral load; and response to any treatment they may be receiving. Other procedures, such as a biopsy, are done only as needed for standard medical practice, and informed consent is obtained before any such procedure is done. Treatment offered is consistent with standard medical practice; no experimental treatments are offered under this protocol. ...
This study is designed to learn more about HIV infection and the conditions associated with it. Patients 18 years of age or older with known or suspected HIV infection may be eligible for this study. Patients may have participated in previous NIH studies. Participants will have periodic physical examinations and blood tests, including evaluations for responses to treatment. Treatment consistent with accepted standard medical practice will be individualized for each patient. Patients who previously participated in a NIH study will be followed for possible long-term benefits or side effects of treatment. Patients treated with alpha-interferon or interleukin-2 (IL-2) may continue treatment with that medication if it is felt that they might benefit from it. Blood samples may be drawn as part of standard medical care and for research purposes. Other tests may be done as appropriate for diagnosis and treatment, including, for example, a chest X-ray, electrocardiogram, or tissue biopsy. Patients will be seen for follow-up visits at regular intervals to monitor treatment progress. Certain patients currently enrolled in a NIH study of IL-2 treatment may participate in a phase of the study that adds a corticosteroid, such as hydrocortisone, prednisone, or prednisonolone, to the regimen. Patients whose CD4 counts did not increase with IL-2 will receive corticosteroids (by mouth or by vein) in an open manner. Patients who responded to IL-2 therapy will be randomly assigned to receive corticosteroids or a placebo (inactive substance) during IL-2 infusions in a blinded manner, so that neither the patient nor the medical staff will know which patients are receiving the drug and which are receiving a placebo. Participants will be requested to receive at least three rounds of treatment with corticosteroid or placebo. Patients currently taking IL-2 by subcutaneous injection (under the skin) may participate in an optional part of the study to receive future IL-2 cycles at home instead of at or near the Clinical Center. Patients who have shown an ability to self-administer and tolerate IL-2 injections with minimal supervision and minimal side effects may be eligible for this option. Home administration of IL-2 involves less frequent data and safety monitoring, and no on-site medical evaluation at the very beginning of each cycle. Participants will continue to be seen at the Clinical Center for regularly scheduled follow-up visits and medical evaluations before the start of each IL-2 cycle to determine if it is safe to begin that cycle. Patients will have a case manager who will place monitoring calls on days 2 and 4 of the cycle and a third follow-up call 1 week later. Patients will be responsible for contacting a study staff member if complications of other problems develop at other times.
This study will identify genetic factors associated with the development of progressive multifocal leukoencephalopathy (PML) in patients with acquired immunodeficiency syndrome (AIDS). PML is a life-threatening infection of the brain that affects about 5 percent of untreated patients with AIDS. Its symptoms include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and coma. PML is caused by a polyomavirus called the JC virus. It is estimated that up to 80 percent of the human population has been exposed to the JC virus, but the disease is very rare. The virus only becomes active in people who have compromised immune systems, such as those undergoing immune suppressive chemotherapy for cancer and those with damaged immune systems due to HIV. Patients who have participated in the Multicenter AIDS Cohort Study may be eligible for this study, as well as healthy normal volunteers who will serve as controls. The study will review clinical information from patients and analyze genetic factors from both patients and control subjects to investigate genes associated with AIDS and JC virus infection.
This study will investigate what factors may lead to the development of immune reconstitution syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also seek to better define and describe the syndrome. IRIS is a condition that can occur in HIV-infected people following the start of antiretroviral therapy. The sudden improvement of immune function with this therapy can cause an unexpected worsening of diseases the patient already has, such as tuberculosis or fungal infections, and development of fever, enlarged lymph nodes or other complications, or even uncover a previously silent disease. HIV-infected people who are at least 18 years old, whose CD4+T cell count is 100 cells per microliter or less, and who have not previously been treated with combination antiretroviral therapy or have taken the drugs for less than 3 months and more than 6 months before screening for this study may be eligible to participate. Candindates must also live within the wider DC area so that acute problems after therapy initiation will be evaluated at NIH. Candidates are evaluated before starting therapy with a medical history and physical examination, blood and urine tests, electrocardiogram, chest x-ray and CT scan of the chest, tuberculin skin testing, apheresis, and possibly an intestinal (gut) and lymph node biopsy (surgical removal of a small piece of tissue for microscopic examination). For apheresis, blood is collected through a needle in an arm vein and spun in a machine that separates the blood components. The white blood cells and plasma are removed, and the red cells and platelets are returned through the same needle or through a needle in a vein in the other arm. Participants have a complete history and physical examination and additional blood tests, including genetic studies, upon entering the study. They start taking anti-HIV medications, prescribed according to the current standard of care, as well as medications to treat other infections, and treatment of IRIS, if needed. The study lasts about 4 years. Patients return to the clinic at 2, 4, 8 and 12 weeks after the entry visit, then every 12 weeks (about every 3 months) until week 48 (the first year), and then every 16 weeks (about every 4 months) until the end of the study. At most visits, patients have a medical history, physical examination and blood and urine tests, including CD4+T cell count and HIV plasma viral load measurement. Apheresis is also done at weeks 24 and 48 and then once every 48 weeks. Intestinal and lymph node biopsies (optional) are also done at weeks 24 and 48. A syphilis test and PAP smear (for women) are done yearly. and plasma, cells and serum are stored at almost every visit for immunologic studies.
This study will examine how HIV affects the brain and nervous system, learning, and behavior in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on this treatment regimen develop significant brain or nervous system problems, such as learning difficulties, attention problems, hyperactivity, and depression. People who acquired HIV disease in the first decade of life and who have evidence of central nervous system (CNS) disease (e.g., encephalopathy, CNS compromise, ADHD, bipolar disease, major depression or psychosis) may be eligible for this study. Candidates are screened with a medical history, physical examination, neuropsychological testing and a CT scan of the head, if one has not been done within 12 months of entering the study. Participants undergo the following tests and procedures: * MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain images of the brain and detect changes in certain brain chemicals that may be affected by HIV infection. Both procedures are done at the same time. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 50 to 60 minutes, during which time the patient can communicate with the staff. * Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to measure their memory, attention, language, problem-solving, academic, and motor skills and questionnaires to assess behavioral and emotional functioning, quality of life, and adherence to HIV medication. Parents are also asked to complete questionnaires assessing their child's behavioral and emotional functioning, quality of life, important life events, and adherence to HIV medication. * Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. Some fluid is collected through the needle. Blood tests and a physical examination are done before the procedure to make sure it can be done as safely as possible. Patients may also be sedated to prevent any discomfort. * Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years after the initial evaluation. Some blood and spinal fluid samples from participants are stored for possible future studies related to HIV research
Many HIV infected patients admitted to the intensive care area (ICA) have never taken anti-HIV drugs. The purpose of this study is to learn whether starting anti-HIV drugs while patients are in an ICA will help them to survive and get better faster. This study will also evaluate patients who, though not in an ICA, have been admitted to the hospital for serious illnesses or infections.
The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection. This study also will look at the safety of using valganciclovir as starting and/or ongoing therapy. CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective against CMV eye infections can be given only by injection; this calls for a thin tube to be placed into a vein in the chest so that the patient is not put through getting too many needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs, ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.
The purpose of this study is to determine whether stopping preventive histoplasmosis medications in patients who are currently receiving effective anti-HIV drugs will place them at risk for getting histoplasmosis again. Histoplasmosis is a serious opportunistic (AIDS-related) infection that responds well to antifungal medications. Before anti-HIV drugs, patients with histoplasmosis required lifelong antifungal therapy. Patients who take anti-HIV drugs for a long time may see an improvement in their immune system functions. Improved immune function may eliminate the need for long-term preventive treatment with antifungal agents. Doctors want to see if the improved immune functions allow preventive treatment for histoplasmosis to be stopped. (This study has been changed to include histoplasmosis treatment with drugs other than itraconazole.)
The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.
The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related \[opportunistic\] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB). HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in the body that fight infection) than HIV-infected patients without TB. HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB. However, its effects in HIV-infected patients with TB are unknown.
The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.
To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.
To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous history of candidiasis.
The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.