Herpes Simplex

Researchers are studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma (HNSCC), a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus (HSV) as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

Researchers are evaluating a combination of immune-targeted therapy and lysogenic herpes simplex virus (HSV) virotherapy as a neoadjuvant treatment for patients with surgically resectable head and neck squamous cell carcinoma (HNSCC). This study aims to improve surgical success and reduce the risk of recurrence and metastasis by using these therapies before surgery. The trial is a prospective, single-arm study focused on the safety and tolerability of this innovative approach for patients with locally advanced HNSCC without distant metastasis. Participants will receive tislelizumab on days 1 and 22, afatinib daily from days 1 to 42, and injections of lysogenic HSV virus into lymph nodes in two doses spaced two weeks apart. The virus dose will be adjusted based on lymph node size, with a dose-escalation phase followed by a dose-expansion phase using the most effective dose. After these treatments, patients will undergo standard surgery to remove the tumor. During the study, researchers will monitor participants for dose-limiting toxicities during surgery and evaluate responses such as major pathologic response and complete pathologic response. Additional assessments include adverse events up to 12 weeks, objective response rate up to 8 weeks, and one-year disease-free survival. Participants will attend scheduled visits for treatment administration, surgery, and follow-up to assess safety and treatment effects throughout the trial period.

Researchers are studying adults aged 18 to 70 years with herpes simplex virus type I stromal keratitis (HSK) to compare the safety and effectiveness of BD111 injection combined with standard therapy against standard therapy alone. This phase 1a, randomized, single-blind clinical trial aims to provide early evidence on how well BD111 works and how safe it is for treating HSK. BD111 is an investigational gene editing therapy designed to target the HSV-1 virus in the eye. The study involves two groups: one receiving a single intrastromal injection of BD111 plus triple-drug therapy (Ganciclovir eye gel, Valaciclovir tablets, and Prednisolone acetate eye drops) for 3 weeks, and the other receiving a sham injection plus the same triple-drug therapy. The BD111 dose is 10^6 TU per eye in a 0.15 mL volume. Participants will be followed for 12 months to monitor safety and treatment effects. During the study, participants will undergo assessments including clinical cure rates at days 70 and 112, viral genome clearance in tears at multiple time points up to one year, recurrence monitoring, corneal inflammation scoring, and vision tests. Blood tests will check for antibodies and vector presence. Safety will be tracked through adverse event reporting. The total participation period is 12 months, with regular monitoring and evaluations throughout.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.

Herpes simplex viruses (HSV) are very common, affecting nearly 90% of people, and stay in the body for life in a dormant state. When the immune system is weakened, HSV can reactivate and cause infections like cold sores or more serious conditions such as meningitis. In intensive care patients on mechanical ventilation with pneumonia, HSV is often detected in the respiratory tract. This research aims to determine whether treating HSV with acyclovir improves survival in these critically ill patients. The study randomly assigns 616 ventilated ICU patients with pneumonia and HSV detected in their lung fluid to receive either acyclovir treatment or no antiviral therapy. Acyclovir is given intravenously at a dose of 10 mg per kg of body weight every 8 hours for up to 10 days or until ICU discharge if earlier. The trial compares survival rates after 30 days between the two groups and also looks at ventilation-free days, vasopressor-free days, and safety outcomes. Participants will be closely monitored during the study with regular assessments including organ function scores, kidney function tests, microbiological cure, length of ICU and hospital stay, and quality of life measures up to 180 days. Safety will be tracked by recording serious adverse events. This comprehensive evaluation will help clarify whether antiviral therapy benefits ventilated patients with pneumonia and HSV in their lungs.

This research aims to improve the use of HIV, STI, and HCV prevention and care services among racially and ethnically diverse gay, bisexual, and other men who have sex with men (GBMSM) and transgender women living in rural Appalachia. By combining peer navigation with mobile health (mHealth) strategies, the study seeks to reduce health disparities in these vulnerable populations and inform public health practices and policies. Participants will be assigned to one of two groups: an intervention group receiving a culturally compatible, bilingual approach that includes peer navigation and mHealth communication, or a delayed-intervention group. Community health leaders will raise awareness, support service access, and conduct in-person group sessions over 12 months. They will also use social media and apps to communicate and support participants throughout the intervention. During the study, researchers will track HIV, STI, and HCV testing rates at baseline, immediately after the 12-month intervention, and again 12 months later. They will also monitor the use of prevention methods like PrEP, syringe services, and gender-affirming care. Participants will be involved in group activities, receive ongoing support via mHealth platforms, and have their service use regularly assessed to measure the intervention's impact through 24 months from baseline.

Researchers are evaluating a behavior change intervention program designed to reduce risky sexual behaviors among college students aged 16 to 24. This program was developed using the Behavior Change Wheel (BCW) theory and includes input from literature analysis, expert feedback, and pre-experiments. The goal is to improve students' psychosexual health, social support, sexual self-efficacy, risk perception, and decision-making ability to lower the occurrence of risky sexual behaviors and related adverse outcomes. The intervention involves a behavioral program aimed at college students who have engaged in risky sexual behaviors such as multiple partners, unprotected sex, or casual sex. Participants are randomly assigned to either the intervention group receiving this program or a control group with no intervention. The intervention lasts 12 weeks, with evaluations before the intervention (T0) and after its completion (12 weeks, T1). During the study, participants will be assessed using scales measuring sexual mental health, social support, and sexual self-efficacy at both T0 and T1. The study monitors changes in these areas to determine the intervention's impact. Participation involves completing questionnaires and assessments related to psychosexual health and social factors, with the entire involvement spanning the 12-week intervention period.

Researchers are investigating the best ways to detect recurrence in women with vulva cancer. This Danish nationwide multicenter study aims to improve treatment and follow-up programs by combining patient-reported outcomes with clinical data. The team also plans to explore if circulating tumor-DNA (ctDNA) can be found in blood samples, which may help identify early signs of cancer returning. The study includes 295 patients in the clinical group and compares results to a historical control group of 1,000 patients diagnosed between 2011 and 2022. All participants will undergo regular collection of patient-reported outcome measures every four months during their surveillance period, along with liquid biopsies to measure ctDNA at baseline and throughout follow-up. Based on patient responses, nurse telephone interviews will be conducted using an algorithm to guide care. The historical control group data will be obtained from the Danish Gynecological Cancer Database for comparison. The study is non-randomized and open-label. Participants will be followed for up to two years or until cancer recurrence. Data collected will include symptom reports, ctDNA levels, and procedural actions taken during their care pathway. The study will assess recurrence-free survival and overall survival over two years, along with quality of life and symptom management. This comprehensive monitoring aims to detect relapse early and improve management of late effects from treatment.

Trigeminal herpetic neuralgia, a common form of Zoster-associated Pain (ZAP), affects people of all ages and poses a significant burden worldwide. Researchers are conducting a randomized controlled trial to evaluate electroacupuncture (EA) as a treatment for ZAP, focusing on its effectiveness and safety compared to pregabalin. The study aims to determine if EA can be a substitute for pregabalin in managing this condition. Participants are randomly assigned to one of three groups: a medication group taking 150 mg pregabalin capsules twice daily for 4 weeks; an EA group receiving electroacupuncture treatments three times per week for 4 weeks (total of 12 sessions), targeting specific acupoints on the affected side with electrical stimulation; and a combined EA plus medication group receiving both treatments concurrently. Each group undergoes a 3-month follow-up period after the interventions. During the study, participants will be assessed using the Visual Analog Score at baseline, during treatment, and in follow-up visits up to 16 weeks. Additional evaluations include pain questionnaires, sleep quality scales, depression and anxiety ratings, and health surveys. Researchers will monitor safety and treatment adherence throughout the study, which lasts several months from enrollment to final follow-up assessments.

Researchers are evaluating the STRATICYTE12 predictive model to see how well it can predict the transformation of oral potentially malignant disorders (OPMDs) into oral squamous cell carcinoma (OSCC). This study focuses on a retrospective group of patients who had biopsies taken for oral lesions. The main goals include assessing the model's sensitivity and specificity, understanding which patient and clinical factors affect its accuracy, and estimating how STRATICYTE12 results relate to the time until a positive oral cancer diagnosis. The study involves analyzing biopsy tissue samples from patients with various grades of oral epithelial dysplasia, including no dysplasia, mild, moderate, severe dysplasia, and carcinoma in situ (CIS). Participants are grouped based on whether their OPMDs progressed to OSCC or not. STRATICYTE12 testing is used to assess the risk of progression to oral cancer by reviewing archived biopsy tissue blocks from clinical centers. Participants' archived biopsy data and clinical follow-up records over at least five years are reviewed. Researchers measure the STRATICYTE12 test's sensitivity, specificity, area under the curve (AUC), and Harrell's C-index, along with survival analysis over five years. The study tracks the correlation of STRATICYTE12 outcomes with oral cancer development timing. No new treatments or procedures are performed during this observational study, and the overall participation involves data analysis from past biopsies and clinical records.