71 Clinical Trials for Various Conditions
This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
Background: Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help. Objective: To find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors. Eligibility: People ages 18 and older with KS. Design: Participants will be screened with some or all of the following: Medical history Physical exam Blood and urine tests Chest x-ray and/or computed tomography scans Lung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ) Medicine review Heart function tests KS lesion assessment Skin sample from a KS lesion Treatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects. Participants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed. Participants will have follow-up visits for up to 2 years after treatment ends.
Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.
The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how long it persists in different body compartments, including mucosal tissues, as it may be considered for PrEP or PEP regimens in the future.
The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.
The proposed research study will focus on Black men who have sex with men (BMSM) who * are HIV- or unknown status AND * have not received HIV testing in over a year or * who test irregularly (on 9/21/2016, the protocol was changed to modify the last to criteria and focus on those who have not used PrEP in the prior six months). and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention (including PrEP), testing, care, and treatment services. The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design. Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules. The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples. For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project. After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.
Men who have sex with men make up a majority of incident HIV infections, however few effective interventions to prevent HIV transmission among this group exist. African American men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is understood about how the role of stigma impacts their linkage and retention to health care during treatment. Effective strategies for reducing HIV related risk taking are urgently needed to prevent further spread of the HIV epidemic. The proposed research will test a behavioral intervention, which can be used during routine public health services, designed to reduce HIV risks posed by sexual partner selection strategies. The proposed research will also identify treatment barriers among MSM who test HIV/STI positive. Effective strategies for reducing social barriers to health care treatment rely on a comprehensive and thorough investigation into social barriers that affect AAMSM to effectively engage in medical care. These areas of research will be focused on for the current trial.
The health of the immune system in HIV infected people is currently determined from a blood test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells play a critical role in an immune response. Studies have shown that low numbers (below the normal range) of CD4 T lymphocytes indicates a defect in the immune system. Conversely, the number of CD4 T lymphocytes within the normal range generally indicates a normal immune system. When a person is infected with HIV the CD4 T lymphocytes are attacked and destroyed and the numbers decline meaning that the immune system can no longer effectively protect the body from infection or cancers. However, when the HIV infected person is successfully treated with Highly Active Antiretroviral Therapy (HAART) the CD4 T lymphocytes numbers increase and may end up in the normal range but the immune system may still not function properly as a number of these cells are incapable of functioning properly. It would be interesting to know how functional the immune system is rather than the number of cells. For this, the QuantiFERON® Monitor (QFM or CST007) test is an experimental diagnostic test used in this study to measure the immune function from people infected with HIV. The objective of this study is to evaluate the usefulness of the QFM test in HIV infected people compared with uninfected people by measuring the function of the immune system. The QFM test measures interferon-gamma released in the plasma following incubation of heparinised whole blood with a combination of stimulants. As immune function is directly influenced by cells with actively replicating HIV an additional research test called the HIV Reservoir Test will be included to better understand the level of immune function in each study subject. How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical Study Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks from Dr. Gatpolintan' office). Study outcome measures (Correlation between QFM and CD4 counts and CD4/CD8 ratios) will be assessed, including data presentation, within an average period of 1 year after study subject enrollment.
The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis.
The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®. Concentrations of the active drug will be measured in blood (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5 days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV infectivity.
This study seeks to evaluate the efficacy of a contingency management (CM) intervention compared to a yoked control condition for eliminating illicit stimulant use and for decreasing time to initiating post exposure prophylaxis (PEP), for improving adherence to PEP, and for completing PEP following a potential HIV-exposure event. Men who have sex with men who use cocaine amphetamine or methamphetamine frequently also have high risk sexual behaviors during or after their drug use. The objective of this study evaluates whether the use of CM that targets stimulant use significantly aids men who have sex with men who use stimulants and also engage in high-risk sexual transmission behaviors to be able to initiate, adhere to and complete PEP, thereby optimizing the utility of a biomedical HIV prevention intervention for reducing HIV incidence in this very high-risk group of MSM.
HIV-uninfected children born to HIV+ women have low level heart problems at birth which may predispose them to heart failure, arrythmias and heart attack later in life. The impact of these heart problems on future heart health is unclear as it is unknown if heart problems in these children persist, worsen or resolve in pre-pubescence. The objective of this study is to characterize heart function in HIV-negative pre-pubertal children born to HIV+ women and exposed to HIV and HAART in utero and compare them to age and gender matched healthy children born to HIV-negative women. Through this objective we will determine if heart problems in HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or resolves during pre-pubescence.
The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.
Background: * Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. However, they can still become re-infected with the same or a different HPV type, and in some people HPV infection persists. * Persistent HPV infection is associated with the development of precancerous lesions and cancer. HPV types are classified as either high risk or low risk based on whether their persistence will lead to cancer. * Patients who have suppressed immune systems are at a higher risk for HPV-related complications. They are more likely to contract multiple HPV types and have more persistent infection that can lead to precancerous lesions or cancer, which are then difficult to treat and often recur. * A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was shown to be highly effective in preventing infection with these HPV types, and is approved for use in females 9 to 26 years of age. However, much less is known about the vaccines ability to induce immunity in males or individuals with suppressed immune systems. Objectives: - To investigate whether the HPV vaccine is safe to give and able to induce immunity in both female and male adolescents and young adults with HIV infection compared to healthy, human immunodeficiency virus (HIV)-negative persons of the same age. Eligibility: - Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on antiretroviral therapy. Design: * Before beginning vaccination, participants will have a complete physical examination and blood drawn for routine blood tests, special tests of the immune system, antibody tests, and an HIV test. * HPV vaccine will be given by injection into the muscle at 0, 2, and 6 months, according to the standard vaccination schedule. * Patients with HIV infection will be monitored for a week following the first injection to test the level of HIV in the blood 3 days and 5 days after the first injection. * Participants will also be asked to fill out a 10- to 15-minute Web-based survey about awareness, health behaviors, and personal choices related to risk factors for HIV, HPV, and other sexually transmitted diseases. Participants are not required to fill out the survey to receive the vaccine. * The total duration of the study is 4 years. During the first year of the study, participants will return for six additional 1-day visits at months 1, 2, 3, 6, 7, and 12. Participants will return for 1-day visits every 6 months for the remaining 3 years.
This study is looking at 3 different types of enemas used before receptive anal intercourse in men who have sex with men (MSM). We are investigating whether the enemas cause any damage to the lining of the colon, how far up the colon the enemas travel after they are given, and how much study participants like using each of the enemas.
The purpose of this study is to evaluate the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA) in HIV uninfected adults.
This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in this study. Study volunteers will be given one of the 4 study drugs or a comparison antibiotic, Isoniazid, which has been used around the world as a standard of care treatment for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return for a final health check. All volunteers will receive 6 months of standard tuberculosis treatment.
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).
This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that is produced by the body and is involved in blood vessel growth. Bevacizumab may block the action of VEGF, and thus help shrink KS lesions. Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and is not life threatening may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, and, if needed, imaging studies to evaluate internal tumors. Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at a slower infusion rate. Patients will be evaluated with the following tests and procedures: * Physical examination, assessment of drug side effects, measurement of KS lesions, and photographs of lesions once a week for the first 6 weeks of therapy, and then every 3 weeks. * cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV) viral load in HIV-positive patients every 12 weeks. * Biopsies of lesions: upon entering the study, at week 12, and at the time of a response of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or later. * Additional biopsies, if requested. (Additional biopsies are not required.) * Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI) scans, if medically indicated. Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open.
The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).
The purpose of this study is to measure the blood levels of amprenavir (APV) alone, APV combined with efavirenz (EFV), and APV/EFV combined with a third drug (nelfinavir \[NFV\], indinavir \[IDV\], ritonavir soft gel capsules \[RTV sgc\], or saquinavir soft gel capsules \[SQV sgc\]). Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV infections. Doctors need to know the best dosages of certain drugs when they are given in combination. This study will measure the blood levels of APV alone, APV combined with EFV, and APV/EFV plus a second PI in healthy volunteers. It will study the safety and tolerance of these drugs.
The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who are at risk from becoming infected with HIV. Patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep HIV levels (viral load) low.
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.
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 evaluate HIV-negative patients with unusually low levels of CD4+ T lymphocytes (a type of white blood cell) to learn more about the clinical symptoms, cause, immunology, and biology of this problem. CD4+ T lymphocytes play an important role in immune function, and low counts may leave people susceptible to unusual infections. CD4+ T cell deficiencies are most often associated with HIV infection. Patients 8 years of age and older with CD4+ T cell counts below 300 cells/mm3 who test negative for HIV infection by standard blood tests may be eligible for this study. Patients' family members and partners may also be enrolled to investigate the possible role of a genetic factor or exposure to some agent in this problem. Patients will be evaluated at the NIH Clinical Center at least once, and generally two or more times. The evaluations, which may be done on an inpatient or outpatient basis, will include some or all of the following tests and procedures: * Complete physical examination. * Medical history, including questions about sexual contacts, intravenous drug use, travel, blood transfusions, previous illnesses, including sexually transmitted diseases, and health of family members. * Urine test. * Blood tests for routine and research purposes, including tests for HIV, hepatitis, syphilis and other infections, evaluation of immune function, and culture for viruses in the HIV family. No more than 1 pint of blood will be drawn every 6 weeks. * Pregnancy test for women of childbearing potential. * Skin tests for tuberculosis and immune function. These tests involve injecting a small amount of the substance to be tested just under the skin and looking for a raised area 1 to 2 days later. * Apheresis. Whole blood is collected through an arm vein (similar to donating blood), and circulated through a cell separator machine, where it is spun to separate the components. The red cells are then returned to the patient either through the same needle or through a needle in the other arm, and the plasma and white cells are extracted for study. The procedure, which takes 1 to 2 hours, may be repeated up to 3 times. Family members will have 60 cc (4 tablespoons) of blood drawn to determine CD4+ T cell counts.
The purpose of this study is to see if it is safe to give an HIV vaccine (vCP205) to volunteers who received an HIV vaccine at least 2 years ago, and to study how the immune system responds to this vaccine. Vaccines are given to people to try to resist infection or prevent disease. There are a number of different HIV vaccines that are currently being tested. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines; the vaccine tested in this study is ALVAC-HIV vCP205. This study will look at the safety of the vaccine and how the immune system responds to it.
The purpose of this study is to find out whether three different anti-HIV vaccines are safe and whether they help prevent HIV infection. These vaccines are called vCP205, vCP1433, and vCP1452. Some patients also receive another anti-HIV vaccine, gp160. The vaccines are made up of small pieces of HIV, which help the body learn to recognize and destroy HIV. You cannot get HIV from these vaccines. There are two different ways a vaccine can protect the body from infection. First, a vaccine may help the immune system make antibodies, which are proteins that recognize invading viruses or bacteria. Second, a vaccine may help the body make immune cells that destroy infected cells. The second type of vaccine is more powerful against HIV. In this study, doctors will see whether vCP205, vCP1433, vCP1452, and gp160 are good vaccines by seeing whether they help the body make immune cells.