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Showing 1-20 of 3,029 trials
NCT04929028
This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back.
NCT07115498
This project will develop and test a novel intervention to improve HIV treatment adherence among young adults with HIV who attend an HIV clinic in Kumasi, Ghana. The intervention is called incentivized Text-Based Adherence Game (iTAG). It is delivered solely via text messages and includes many advanced features including a point system that rewards participants for responding to texts, a scoreboard that compares participants' progress with each other, and messages on a range of health and HIV-related topics. To evaluate iTAG, study staff will recruit 20 young people, ages 18-24, with HIV (YPWH) to complete 90 days worth of intervention text messages. Before and after receiving iTAG messages, they will complete computer assessments used to measure HIV medication adherence as well as other factors believed to be influence adherence such as social support. By examining participants score from before and after receiving the intervention, and by talking with participants after they receive the intervention, it will be understood whether iTAG is acceptable to YPWH and could potential lead to improvements in participants' HIV treatment adherence.
NCT07466836
The main aim of this pilot trial is to investigate the feasibility of undertaking a randomized controlled trial involving adults living with HIV. Additionally, this trial will explore potential change differences in self-reported quality of life and blood-derived immune markers between a chiropractic care group and no treatment controls.
NCT06045923
The purpose of this study is to examine the extent of mpox viral spread and immunologic markers in people with advanced HIV. Study findings will enhance knowledge of mpox pathogenesis in severely immunocompromised people, which can inform treatment and prevention of severe illness and deaths associated with mpox in people with advanced HIV.
NCT07564180
Effect of spinal anesthesia with bupivacaine versus prilocaine on postoperative shivering after inguinal hernia repair : a prospective randomized double blind study
NCT05729568
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
NCT06784908
This is a basic human experimental study utilizing 4 groups of individuals with and without HIV and complex morbidities of cannabis use disorder and major depression who will participate in 2 sessions of the Yale Pain Stress Task (YPST) and follow-up phase to assess drug use and mood symptoms.
NCT06749054
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill. The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.
NCT01875588
Background: \- People with human immunodeficiency virus (HIV) can sometimes develop thinking and memory problems. These problems can vary widely, from few symptoms to severe problems with memory and concentration. It initially was thought that good HIV treatment could prevent almost all HIV-related memory problems. However, even people with low HIV viral loads can have these problems. It may be caused by HIV affecting the brain and spinal fluid. It is not yet clear why HIV causes these problems and why they may be worse in some people than others. Researchers want to study people with HIV and healthy volunteers to see how HIV may affect people with only small amounts of the virus in their blood. Objectives: \- To study thinking and memory problems in individuals with HIV that is otherwise controlled with medications. Eligibility: * Individuals between 18 of age or older whose HIV has been controlled with medications for at least 1 year. * Healthy volunteers between 18 of age or older. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A neurological test will also be given. Participants will have a baseline imaging study of the brain. * Within 12 weeks of the first visit, participants will have a second visit. Additional blood samples will be drawn. Another brain imaging study will be performed. * Within 8 weeks of the second visit, participants will have a third visit to collect more blood samples. They will also provide spinal fluid samples, either as a single visit or a longer procedure. * After this visit, participants will return every 12 months for up to 10 years. Blood samples will be collected as needed at these visits. Thinking and memory tests and imaging studies may also be given as needed. Spinal fluid may be collected at one visit a year....
NCT01125228
This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system deterioration, and increasing the time to development of the first opportunistic infection in HIV-infected patients. HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more and no current opportunistic infections may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, chest X-ray, electrocardiogram, urinalysis, and, for patients with Kaposi s sarcoma lesions, measurement, photographs, and biopsy of lesions. Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus interferon or interferon alone. They will continue treatment until one of the following occurs: * Unacceptable side effects, despite dose modifications * Development of an opportunistic infection * Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3 * Rapid progression of Kaposi s sarcoma lesions, requiring alternative therapy * A decision is made to terminate the study Patients will be followed long term for viral load, immune function, development of opportunistic infections, disease progression, and survival. ...
NCT07546344
This is a pilot cluster-randomized control trial co-led by Dr. Valentina Cambiano, Associate Professor of Epidemiology at University College London, UK and Professor Euphemia Sibanda, Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe). The goal of the proposed study is to evaluate the appropriateness, feasibility, acceptability, uptake, costs and cost-effectiveness of a community-based, HIV-status neutral peer-led service delivery model in which young mentor mothers (YMM) work with pregnant and lactating adolescent girls and young women (PL-AGYW, aged 15-24), up to two-years post-birth, in Zimbabwe to promote uptake of contraception and HIV prevention. YMM living with HIV have been found to be effective in supporting their peers for prevention of mother-to-child transmission of HIV and adherence to treatment through the "Zvandiri" programme. The investigators propose adapting the "Zvandiri" YMM to include those without HIV to promote behaviour to prevent HIV and unintended pregnancies. This proposed intervention is building on the formative work that had the overall aim of co-developing with AGYW (aged 15-24) a Pre-Exposure Prophylaxis (PrEP) implementation intervention for AGYW who need it, that attracts them to PrEP, and supports pregnant and lactating adolescent girls and young women while taking it.
NCT05551273
The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level \>1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.
NCT05360849
Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs, thereby reducing new HIV infections in this population.
NCT00001471
This study will examine tissue from the tonsils, lymph nodes and large bowel of HIV-infected patients to investigate changes in viral load and certain white blood cells during treatment. Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly an electrocardiogram (EKG). Blood tests may include HLA typing, a genetic test of immune system markers. Participants may undergo the following procedures: * Blood tests (patients and volunteers) * Biopsies The frequency of biopsies for given patients may vary, depending on their specific therapy. Typically, biopsies are done at a single time, or for patients starting a new therapy, biopsies could be performed before starting therapy, during therapy and possibly after completion of therapy. * Tonsil biopsies (patients and volunteers) Volunteers will have one tonsil biopsy. Patients will have no more than six tonsil biopsies, with no more than three in a 10-day period. The biopsy is done by an ear, nose and throat specialist as an outpatient procedure. The tonsils are numbed with a local anesthetic, and one to four pieces of tissue are extracted. * Lymph node biopsies (patients only) Patients will have no more than four lymph node biopsies, performed no more frequently than once a month. The biopsy is done by a surgeon and may require a 2- to 3-day hospital stay. The skin above the lymph nodes is numbed with a local anesthetic, an incision is made and the tissue is removed. Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site. * Intestinal biopsies (patients and volunteers) Volunteers will have one intestinal biopsy procedure. Patients may have up to six intestinal biopsy procedures, each separated by at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A flexible tube (sigmoidoscope or colonoscope) with a light and special lens at the tip is inserted into the rectum and large bowel. Wire instruments passed through the tube are used to extract small tissue samples. * Bronchoalveolar lavage (BAL; patients and volunteers) Volunteers and patients will undergo bronchoscopy in which a flexible tube (bronchoscope) with a light and special lens at the tip is inserted through the nose or mouth into the lungs, and the lining of the lung is sampled by washing the airways with small amounts of saline. The procedure is performed by a pulmonologist or critical care specialist, usually as an outpatient.
NCT07064785
This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. The study will be conducted in health facilities which provide HIV care to teens/adolescents in the Machinga and Balaka districts of Malawi with approximately 900 teens living with HIV and their treatment supporters (dyads). Dyads will be individually randomized on a 1:1 ratio to receive either the intervention or the standard of care. The VS4A intervention is designed to support Information, Motivation, and Behavioral skills (IMB) around adolescent ART adherence as well as strategies for enhancing treatment supporter social support. The intervention consists of: 1) a two-session video package with associated activities that both the adolescent and their treatment supporter will be asked to watch and participate in; 2) ART refill for the adolescent; 3) and intensive adherence counselling for those with a high viral load. The primary outcomes are adoption of the intervention and adolescent viral load suppression. The overall hypothesis is that VS4A will achieve high adoption and improve adolescent viral suppression.
NCT06694805
This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
NCT02437851
This phase II trial studies surgery in treating patients with anal canal or perianal cancer that is small and has not spread deeply into the tissues and human immunodeficiency virus (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.
NCT07376239
This observational case-control study evaluates quality of life, depressive symptoms, and sexual function in heterosexual men living with HIV who are receiving effective combination antiretroviral therapy and have achieved virologic suppression, compared with healthy male controls. Participants complete validated questionnaires assessing quality of life (EUROHIS-QOL-8), depression (Beck Depression Inventory), and sexual function (Arizona Sexual Experience Scale). The study aims to identify psychosocial and sexual health challenges that may persist despite effective HIV treatment.
NCT07535346
This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.
NCT06004830
This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.