View clinical trials related to HIV Infection.
Filter by:This study will examine how quickly white blood cells called CD4 lymphocytes reproduce and how long they live in people infected with HIV. It will do this using bromodeoxyuridine (BrDU), a compound that is structurally similar to thymidine, one of the building blocks of DNA. BrDU gets incorporated into DNA instead of thymidine, but it can only get into cells that are replicating. Therefore, measuring the proportion of cells with BrDU indicates how many cells are replicating. HIV-infected patients 18 years of age and older may be eligible for this study. Candidates will be screened with a medical history, physical examination, chest X-ray, electrocardiogram (EKG) and blood tests. Participants will be given an infusion of BrDU through a catheter (thin plastic tube) placed in an arm vein. Blood will be drawn up to 4 times in the first 24 hours after the infusion. Additional samples will then be collected as often as daily for the first week, twice a week for the next 3 weeks and then weekly to monthly for up to 1 year. Some patients may undergo a tissue biopsy (removal of a small tissue sample from a lymph node, tonsil or colon) or computed tomography (CT) scans of the thymus (a small gland between the lungs that manufactures lymphocytes. Some patients will have a second infusion in order to examine changes in the rate of CD4 replication over time or following potent antiretroviral therapy. Patients will be followed in the clinic periodically for the first year and then will be seen in the clinic or contacted by telephone once a year for 4 more years. The results of this study may provide a better understanding of how HIV causes disease and how therapy affects the immune system.
This study will evaluate the safety and immune system effects of infusing HIV-infected patients with multiple doses of lymphocytes (white blood cells) from their non-infected identical twin. It will determine whether the donated lymphocytes can improve immune function and reduce viral load in the infected twin. Identical twin pairs-one who is infected with HIV-1 and one who is negative for the virus-may be eligible for this study. Candidates will be screened with blood tests, a medical history and physical examination. Both twin participants will receive a tetanus booster shot, if needed. The non-infected twin will undergo apheresis to collect white blood cells. For this procedure, whole blood is collected, similar to the procedure for donating a unit of blood from a needle in the arm. The blood flows through a cell separator machine where the white cells are removed, and the rest of the blood (red cells, plasma and platelets) is returned to the donor through a catheter in the opposite arm. The collected lymphocytes will be given intravenously (through a vein) to the infected twin over a 60-minute period. This procedure-apheresis and infusions-will be repeated 4 days a week to complete one cycle. The cycles will be repeated about every 8 weeks for 6 cycles (about 1 year). The infected twin will have blood samples drawn on the first day of each cycle, 2 weeks after the beginning of each cycle, and 4 weeks after each cycle to evaluate immune status, viral load and other safety parameters. The frequency of these blood tests may change as the study progresses. The infected twin will also undergo apheresis immediately before each cycle of infusions and one month later to test the white cells for certain immune features. The number of apheresis procedures may be reduced as the study proceeds.
This study will try to define how and where HIV infection persists in the body by determining: 1) if there are cells where HIV can live for long periods of time without being seen and destroyed by the immune system; 2) if there are sites where anti-HIV drugs cannot penetrate enough to stop new HIV replication; and 3) if HIV in certain lymph nodes can remain infectious for prolonged periods of time. It will also explore whether immune system damage caused by HIV can be repaired after new virus replication is stopped with treatment. HIV-infected patients 18 years of age and older may be eligible for this study, which will include three groups as follows. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly chest X-ray and electrocardiogram. Participants will be divided into three groups according to CD4 count levels: > 500 cells/microliter of blood; between 300 and 500 cells/microliter, and < 300 cells/microliter of blood. All participants will be treated with a combination of four antiretroviral drugs: indinavir, zidovudine, lamivudine and nevirapine. (Exceptions to this regimen may be made in certain circumstances for patients who cannot tolerate one of the four drugs.) In addition, they will undergo the following procedures: Blood tests - Blood tests will be done at screening and at study entry to evaluate the patient's health status and measure CD4 T cell count and plasma HIV levels; at the beginning of treatment to look for drug-related side effects; and during the course of the study to evaluate drug effectiveness in inhibiting HIV replication; CD4 T cell levels and function. Lymph node biopsy - Lymph node biopsies are done under local anesthesia. A small incision is made, the node is removed, and the incision is closed with stitches. Up to two nodes may be removed during each procedure. Patients with CD4 counts greater than 500 cells/microliter of blood and those with counts less than 300 cells/microliter will have three lymph node biopsies in order to 1) assess the effectiveness of therapy in inhibiting HIV replication in the nodes (the major site of replication); 2) determine how long HIV-infected cells may persist in the nodes after new replication is stopped by therapy; and 3) determine if immune damage caused by HIV can be repaired when virus replication is stopped. Lymph node biopsy in patients with counts between 300 and 500 cells/microliter of blood is required only at baseline, although follow-up biopsies are encouraged. Leukapheresis - In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a cell separator machine where the white cells are removed and collected. The rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. The collected white cells are used for special studies of the level and function of T cells before and after drug treatment. Patients with CD4 counts > 500 cells/microliter and < 300 cells/microliter will undergo leukapheresis up to four times - at study entry and about 2, 6 and 12 months after starting antiretroviral therapy. Patients with CD4 counts between 300 and 500 cells/microliter will have this procedure either at study entry and 6 and 12 weeks after initiation therapy, or on the same schedule as the other patients.
This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral infection of the eye-can safely be stopped in HIV-infected patients whose immune function has improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir, foscarnet, and cidofovir) can cause serious side effects, such as low blood counts and kidney damage. Stopping these medications may, therefore, be beneficial. Patients with HIV infection who develop CVM retinitis usually have very low levels of infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of blood. New anti-HIV medications have been able to raise CD4 levels and improve immune function in many patients. This study will see if patients with CD4 levels above 150 cells per microliter can fight CVM retinitis without additional anti-CVM drugs. HIV-infected patients with CVM retinitis will have a physical examination and complete eye examination. These tests will be repeated after 2 weeks. If there is no evidence that the CMV infection has progressed, and if it is in a location that is not immediately sight-threatening, anti-CMV medications will be stopped. Patients will be examined every 2 weeks for 3 months and then every 3 weeks for the next 3 months. Patients whose CD4 count has remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM infection becomes active again. At that time, anti-CVM medicines will be re-started. Patients will also have blood and urine samples taken to test for levels of HIV and CMV in the blood and urine, and will be interviewed about their vision and how it affects daily activities.
This is a randomized, double blind study of the safety and immunogenicity of APL 400-003, a plasmid DNA vaccine encoding the env and rev genes of HIV-1, in HIV-negative volunteers. Three doses of vaccine are being tested: 100, 300, and 1000 micro g. 8 volunteers per dose will be randomized: 6 to plasmid vaccine, and 2 to a vehicle control. Immunizations will be administered at day 0 and weeks 4 and 8, with a booster immunization administered at week 24. An additional 5 volunteers may be included in an open manner at the dose likely to be used in subsequent studies. The primary aims of the study are to determine: 1. the safety of APL 400-003, as evaluated by clinical and laboratory safety parameters and 2. the immunogenicity of APL 400-003, as determined by a broad range of laboratory assays. Up to 33 patients (allowing for drop-outs) will be enrolled in the study, and volunteers will be followed for one year after immunization.
This study will test the safety and effectiveness of genetically altered T lymphocytes (white blood cells of the immune system) in reducing viral load in patients infected with the human immunodeficiency virus (HIV). The lymphocytes will have two genes inserted into them; a laboratory-manufactured anti-HIV gene designed to inhibit HIV reproduction (either the RevTD or Rev-TD-antiTAR gene), and a "marker" gene that will show whether or not the inserted genes have gotten into the cells. Identical twin pairs 18 years of age and older- one of whom is HIV-positive (infected with the human immunodeficiency virus) and the other HIV-negative (not infected) may be eligible for this study. All participants will have a complete medical history and physical examination, blood tests and a tetanus booster shot, if indicated. The non HIV-infected twin will then undergo lymphapheresis to collect lymphocytes. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The lymphocytes are then removed, and the red cells and plasma are returned to the donor, either through the same needle or through a second needle placed in the other arm. The donor cells are grown in the laboratory for a few days, and then the new genes are inserted into them. The genetically altered cells are grown in the laboratory for several days until their numbers increase approximately a thousand-fold. They are then infused intravenously (through a vein) into the infected twin. These procedures-lymphapheresis, gene modification and infusion-will be repeated at approximately 2-month intervals up to four times. Each lymphocyte infusion takes about 60 minutes. The patient's vital signs (temperature, pulse, blood pressure and breathing) are monitored frequently during the infusion and hourly for 4 hours after the infusion. Blood samples are taken the day of the infusion, 3 days later, and then weekly to monitor the gene-modified cells, immune status, viral activity, and other factors. These tests may be done less often as the study progresses and more is learned about the safety of the infusions. The infusions are done on an outpatient basis unless side effects require that they be done in the hospital with post-infusion monitoring for at least 24 hours. Patients will be followed for long-term effects of treatment monthly for the first 3 months, once a month for the next 9 months and yearly from then on. This study will contribute information about the use and side effects of gene therapy in HIV infection that may lead to new treatment strategies. A potential direct benefit to HIV-infected individuals participating in this study is reduced viral load; in laboratory studies, the RevTD and Rev-TD-antiTAR genes have inhibited HIV spread in the test tube. However, this is an early phase of study, and the likelihood of receiving this benefit is unknown.
This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
We propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. The main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and HIV/AIDS susceptibility and progression. The subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. Information on tobacco and alcohol use, psychological and personality traits, sexual behavior, HIV status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. DNA will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. By correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.
Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Also, certain patients in this protocol may receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle. To be eligible for home administration of IL-2, patients must: - Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol, with at least two well-tolerated outpatient cycles at a stable dose. - Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions, intravenous fluid replacement or dose reductions. - Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles. - Have a strong relationship with a private physician or health-care provider who has been involved in the patient's care and is willing to help supervise the patient's care during each home IL-2 cycle. - Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff. - Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle, providing the patient non-medical assistance and checking on his or her condition daily. - Have reasonable access to emergency medical services and a nearby medical facility. - Have proved reliable and consistent in using sterile technique, reconstituting IL-2 vials and administering subcutaneous IL-2 injections. - Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation. - Have access to a home weight scale and be able to weigh themselves each day for safety monitoring. Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation. They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle. During the home cycle, the patient's case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness. Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy.
This study is designed as a randomized, open trial of intermittent continuous infusions of Interleukin-2 in HIV seropositive patients with a CD4 cell count between 200 and 500 cells/mm(3). The goal of the study is to determine the optimal duration of each infusion, and the optimal interval between infusions. Thirty-six patients will be randomized to 3 groups: Group A will be the control group with a regimen of five day infusions of IL-2 every eight weeks; Group B will receive IL-2 infusions every eight weeks, however the duration of each infusion will be determined by parameters reflecting T cell proliferation, with discontinuation of each infusion at a point when the response appears to be maximized; Group C will receive five day infusions of IL-2; however the interval between infusions will be determined by the response seen to the prior infusion, with the goal of administering infusions while the CD4 cell count remains above baseline from the prior infusion. The dose of interleukin-2 to be used will be 9 MIU by continuous infusion daily. All patients will be evaluated at the NIH at least every 4 weeks, and at that time safety labs and immune studies will be performed. In addition, patients in Groups B and C will undergo a laboratory evaluation weekly, at which time immune parameters, including CD4 number and percent, spontaneous blast transformation, soluble IL-2 receptor levels, and viral parameters, including branched DNA assay and p24 antigen, will be determined. The study duration will be approximately one year.