View clinical trials related to HIV Infection.
Filter by:Although highly active antiretroviral therapy (HAART) has been successful in suppressing plasma HIV RNA levels in infected patients, it has not resulted in eradication of virus. It is now clear that virus replication persists despite undetectable plasma viremia in individuals receiving HAART. In this regard, withdrawing HAART, even after prolonged periods of virus suppression, leads to an almost universal rapid rebound of plasma viremia. It is also now clear that prolonged, continuous HAART carries a risk of significant toxicity and side effects. These recent observations may argue for a different approach to HAART with the goals of: 1) durable suppression of virus replication, without an attempt at eradication, and 2) minimization of toxicity and side effects and improvement in patient life-style. Therefore, we propose to study the virologic and immunologic effects of intermittent versus continuous HAART in HIV-infected individuals as a possible means to achieve these goals. The primary protocol, Cohort 1, will be a randomized controlled study of 35 individuals receiving continuous HAART and 35 individuals receiving intermittent HAART with intervals of one month off therapy followed by two months on therapy. A second cohort of 10 individuals will serve as a pilot of 2 arms of 5 patients each to evaluate the potential of shorter on-off cycles to maintain suppression of plasma virus and boost HIV-specific immune responses. An extension of Cohort 2 will add 5 patients to the 7 days on/7 days off HAART arm with modified exclusion criteria and procedure schedule. We will analyze CD4+ T-cell counts, viral load, incidence of toxicity and side effects, HIV-specific immune responses and viral resistance to therapy and characterize the virus during rebound plasma viremia.
This study will examine and compare the health-related quality of life and degree of symptom discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One group will receive continuous treatment over the entire 88-week study period; the other will have interruptions in therapy over the same time period. Patients enrolled in the National Institute of Allergy and Infectious Disease's trial, "Immunologic and Virologic Studies of Intermittent versus Continuous HAART [highly active antiretroviral therapy] in the Treatment of HIV Disease," may participate in this study. At periodic intervals for a total of 7 times during the 88-week trial, this companion study will require participants in both the interrupted and the continuous therapy groups to complete the following two questionnaires: 1. MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical and emotional well being. Survey questions are related to the ability to perform work and daily living activities, mood and state of mind, limitations on social activities, ability to concentrate, energy level, pain level, general quality of life, etc. 2. Symptom Distress Scale - The patient rates the degree of symptom distress by ranking from 1 to 5 his or her agreement with statements about various physical and emotional factors, including appetite, nausea, breathing, cough, pain, insomnia, fatigue, bowel problems, concentration, appearance, and outlook. Understanding the impact of HIV treatments on health-related quality of life and symptom distress may provide information helpful in evaluating new treatment approaches.
This study will examine the effects of increases in HIV blood levels on the immune system. A better understanding of how HIV alters the immune response may lead to development of effective immune-based therapies against the virus. Patients 18 years of age or older with HIV-1 infection who have been receiving highly active antiretroviral therapy (HAART) may be eligible for this study. In order to study the effect of increased levels of virus on the immune system, therapy will be stopped in these patients temporarily. Therefore, only patients who have an appropriate level of understanding of the potential benefits of therapy and the risks of stopping treatment will be considered for enrollment. Pregnant women may not participate and women of childbearing potential must agree not to become pregnant during the study. Candidates will be screened with a medical history, physical exam, blood and urine tests and possibly a chest X-ray and electrocardiogram. Upon entering the study, participants will have blood tests to measure the amount of virus in the blood, CD4+ T cell counts, side effects of the medications, and how the patient s immune system responds to HIV in the test tube. White cells will be collected through leukapheresis. In this procedure, a needle is placed in an arm vein and blood flows from the vein through a tube (catheter) into a cell separator machine, where the white cells are separated from the rest of the blood by a spinning process. Some of the white cells are collected by the machine, and the rest of the blood is returned to the body through a second needle placed in the other arm. Patients will then have a physical examination and blood tests every 1 to 2 weeks and will be managed according to their viral load and CD4 cell counts as follows: Viral Load - If viral blood levels remain less than 5000 copies per milliliter, no medical intervention is planned. - If viral blood levels rise to 5,000 copies per ml or higher, patients will undergo a second leukapheresis and re-start antiretroviral therapy. They will be monitored at least monthly until viral load returns to pre-study levels. CD4 Count - If the CD4 count rises or remains at pre-study levels, no intervention is planned. - If the CD4 count decreases by 10 to 25 percent of pre-study levels, the counts will be monitored every 2 weeks at least 3 times and then monthly. - If the CD4 count decreases by 25 percent or more of pre-study values, antiretroviral therapy will be re-started and counts will be monitored until they return to pre-study levels. If viral and CD4 levels do not return to pre-study levels promptly, patients will continue to be monitored and will be advised about possible treatment changes. Alternatively, patients whose viral and CD4 levels are similar to or better than pre-study values may be offered laboratory testing every 3 months for at least 1 year if there is a scientific reason to continue studying the patient s immune system. Patients may be asked to undergo additional leukapheresis in the future, or another interruption of therapy in the future if it is felt safe to do so.
This study will continue to follow children who participated in an earlier National Cancer Institute trial of HIV treatment with a protease inhibitor. Children in this study will receive a combination of at least three drugs that include at least one protease inhibitor and one reverse transcriptase inhibitor. The study will examine to what extent these drugs can restore immune function in HIV-infected children and over what length of time. It will look at changes in the amounts of virus and the specific types of immune cells in the body over the 96-week trial period. It will also examine patients' immune system response to influenza and tetanus vaccinations. The children will either continue to receive the anti-HIV drugs they have been taking, or their medicines will be changed to a different combination of protease inhibitor and reverse transcriptase inhibitor. Before and during the study, patients will undergo various tests, including a physical examination, blood tests and chest X ray, immune response tests, CT scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may be done to collect white blood cells. In this procedure, whole blood is drawn similar to donating blood, the white cells are separated out by a machine, and the red cells are returned to the body.
This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea may help certain anti-HIV drugs to work better and that the virus does not become resistant to it, as it does other drugs. This study will also examine how hydroxyurea affects the body's immune system and virus levels. Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study. They will be screened for eligibility with a thorough physical examination, including chest X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests. All patients in the study will take didanosine twice a day, stavudine twice a day and efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take a low dose of the drug, while others will take a high dose. Within each of these two groups (high and low dose) some patients will start taking hydroxyurea the same day they begin the anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12, then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood tests to measure virus levels will be done every other day for the first 7 days and periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head will be done about every 6 months.
This study examined the interactions of various drugs used to treat HIV infection in order to design larger studies of possible combinations for people who continue to have high viral levels despite combination therapy. HIV-infected patients 18 years of age and older who have a viral load of at least 500 copies/mL; who have received 20 weeks of protease inhibitor therapy, with the same protease inhibitors in combination therapy for the last 12 weeks; and who have never been treated with abacavir, amprenavir or efavirenz were enrolled. All patients will receive 600 milligrams a day of efavirenz (a non-nucleoside reverse transcriptase inhibitor); 300 mg twice daily of abacavir (a nucleoside analog); and 1200 mg twice a day of amprenavir (a protease inhibitor). In addition to these drugs, six patients will receive 500 mg twice a day of ritonavir (a protease inhibitor); six patients will receive 200 mg twice a day of ritonavir; and 10 will receive 1250 mg twice a day of nelfinavir (a protease inhibitor). Patients in the two ritonavir groups (500-mg and 200-mg dose groups) took abacavir and amprenavir for one week and then come to the clinic for blood tests to measure drug levels before taking their morning pills and at 1/2, 1, 2, 4, 8, and 12 hours after taking the medicines. They will then add ritonavir to their treatment regimen. After one week, they will return for blood tests as before. They will then add efavirenz to their regimen and had bloods drawn again after another 1 or 2 weeks. Patients in the nelfinavir group took abacavir, amprenavir and nelfinavir for one week and then have blood sampling as described above for the ritonavir group. They will then add efavirenz to the regimen and repeat the blood tests again after another 1 or 2 weeks. Participants are being seen in the clinic for follow-up only if they wish to continue to participate and if the regimen appears to offer clinical benefit.
This study will examine risk factors for facial wasting and avascular necrosis (AVN, a type of damage to the hip and other bones) in HIV-infected patients. The prevalence and natural history of AVN are also being evaluated. This study will use magnetic resonance imaging (MRI) to identify and monitor these conditions in patients with and without diagnosed AVN and to identify risk factors. HIV-infected patients 18 years of age and older may be eligible for this study. HIV-infected children 4 years and older who can tolerate magnetic resonance imaging without sedation may also participate. Candidates may be screened for participation with a medical history, physical examination, blood and urine tests and possibly an electrocardiogram. Volunteers will provide a medical history and may have a brief physical examination. The study is currently closed to normal volunteers. HIV-infected patients will have a MRI scan of the hip bone, and possibly other bones. Before the scan, they will provide a medical history by interview or questionnaire and have a physical examination. Those with diagnosed AVN will also have blood drawn to help identify potential risk factors for AVN. For the MRI, the patient lies flat on a stretcher that is moved into a cylindrical machine with a strong magnetic field. Earplugs are worn to muffle thumping sounds produced by radio waves that form the images. Patients can speak with a staff member via an intercom system at all times during the procedure. Repeat MRI studies will be requested at approximately 3- to 12-month intervals for up to 5 years, to see if changes occur with time. If medically indicated, additional diagnostic studies may be done to obtain information needed for appropriate medical care. Blood will be drawn periodically to examine immune parameters and viral blood levels. Patients with AVN may have periodic consultations with the rehabilitation medicine service and orthopedic surgeons. ...
This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen). HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome
Following guidelines issued by the Centers for Disease Control, the Clinical Center implemented a Universal Precautions policy in November 1987 in an attempt to reduce healthcare workers' risks for occupational exposures to bloodborne pathogens. All hospital personnel whose jobs entailed potential exposure to patients' blood and body substances were required to attend a training session and complete a written examination. Based on data from surveys conducted before and twelve months after training in Universal Precautions, the frequency of cutaneous exposure to blood decreased by 50% in temporal association with implementation of Universal Precautions. Staff at the Clinical Center are required to take a refresher course in Universal Precautions annually. The prevalence of bloodborne infections is high in Japan; however, Universal Precautions are not widely practiced in Japan. This study is designed: 1) to evaluate and compare nurses' knowledge of the epidemiology, pathogenesis, occupational risks, and appropriate prevention strategies for managing patients infected with bloodborne pathogens in the healthcare setting in seven university hospitals in Japan and at the Clinical Center of the National Institutes of Health in the US; 2) to compare self-reported levels of compliance with existing infection control recommendations designed to limit risk for exposure to bloodborne pathogens in all four institutions; 3) to compare self-reported frequencies of cutaneous exposures to blood at the four hospitals in the study; and 4) to evaluate the effect of educational intervention on nurses perceived compliance with recommendations and on the frequency of self-reported exposures to blood.
This is a pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection. In addition, this study will determine the safety of combination therapy with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected children will be studied, including both moderately and severely immunocompromised individuals. The children will be treated with ritonavir, nevirapine and stavudine or with predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as the repopulation of naive T cells, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire. Drug pharmacokinetic profiles in this regimen will be examined.