Herpes Simplex

Head and Neck Squamous Cell Carcinoma (HNSCC) is a common and serious cancer affecting the head and neck area, with increasing incidence and mortality worldwide. Surgical removal is the primary treatment, but many patients still face risks of cancer returning or spreading after surgery. This clinical study investigates a new approach combining immune-targeted therapy with a lysogenic herpes simplex virus (HSV) as a pre-surgery (neoadjuvant) treatment to improve outcomes for patients with resectable HNSCC. The study includes a single-arm, prospective design evaluating the safety and tolerability of this combined treatment. Participants receive lysogenic HSV virus injections directly into lymph nodes at doses adjusted by lymph node size, given twice with a two-week interval. Alongside, patients are treated with Tislelizumab, an immune drug given intravenously every three weeks, and Afatinib, taken orally once daily. The study consists of dose-escalation and dose-expansion phases to find the optimal virus dose. Participants will be monitored during surgery to assess dose-limiting toxicities. Researchers will evaluate tumor response, immune effects, and safety through clinical assessments, laboratory tests, and imaging. The study aims to reduce tumor size and stage before surgery, improve surgical success, lower recurrence risks, and ultimately enhance patient quality of life and prognosis.

Researchers are evaluating the safety and tolerability of a combination of immune-targeted therapy with neoadjuvant treatment using lysogenic herpes simplex virus (HSV) in patients who have surgically resectable squamous carcinoma of the head and neck. Head and Neck Squamous Cell Carcinoma (HNSCC) is a common and serious cancer in the head and neck area with increasing incidence and mortality worldwide. Surgical removal is the primary treatment, but many patients risk recurrence and spread of the cancer after surgery. Combining immune-targeted therapy and oncolytic HSV virus aims to enhance immune response and directly destroy tumor cells, potentially improving outcomes for these patients. Participants will receive a combination of treatments including Tislelizumab given intravenously every three weeks, daily oral Afatinib, and injections of lysogenic HSV virus into lymph nodes near the tumor. The HSV virus dose will be adjusted based on lymph node size, with two injections spaced two weeks apart. The trial includes a dose-escalation phase to determine the best virus dose, followed by a dose-expansion phase using the optimal dose identified. This is a prospective, single-arm study designed to assess this innovative combined treatment before surgery. Throughout the study, participants will undergo various assessments to monitor safety and treatment effects, including checking for dose-limiting toxicities during surgery. Researchers will evaluate tumor response and patient health with laboratory tests and clinical evaluations. The study requires patients to have adequate organ function and be physically fit for surgery. Participation involves careful follow-up and adherence to study procedures to evaluate the potential benefits and risks of this new neoadjuvant treatment strategy for resectable HNSCC.

Researchers are evaluating the safety, tolerability, and effectiveness of BD111 injection combined with standard therapy versus standard therapy alone in adults aged 18 to 70 years with herpes simplex virus type I stromal keratitis (HSK). This phase 1a, single-blind, randomized clinical trial aims to provide early confirmation of BD111's clinical effectiveness. BD111 is an investigational gene editing treatment designed to target the HSV-1 virus through lentiviral-like particles delivering SpCas9 and gRNA. Participants will be randomly assigned to receive either a single intrastromal injection of BD111 at a dose of 10E6 TU/eye with a volume of 0.15 mL, in addition to a 3-week triple-drug therapy (Ganciclovir eye gel, Valaciclovir tablets, and Prednisolone acetate eye drops), or the triple-drug therapy alone. The study includes a total follow-up period of 12 months to assess safety, tolerability, and treatment efficacy. Throughout the 12-month follow-up, researchers will monitor clinical cure rates of HSK at Day 70 and Day 112 after treatment. Participants will undergo clinical evaluations, including eye function assessments and tear swab tests, and will be closely monitored for treatment safety and tolerability. Study staff will also ensure adherence to contraceptive measures and follow-up visits, with the overall study involving 40 eligible adult participants.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in an open-label, multicenter Phase 1/2 study involving participants with advanced solid tumors that are rich in antigens. This study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 when given as a single intravenous agent. It focuses on patients with unresectable, locally advanced, or metastatic solid tumors, especially those with specific tumor characteristics such as high mutational burden or viral association. The study is divided into two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. During Phase 1, participants receive intravenous STAR0602 to determine its safety profile, maximum tolerated dose, and recommended dose for Phase 2. Phase 2 involves administering STAR0602 at the recommended dose to evaluate safety further and assess clinical activity, including tumor response rates and disease control. STAR0602 is given by intravenous infusion, and dosing schedules follow cycle lengths of 28 days. Participants will be closely monitored throughout the study, including assessments of dose-limiting toxicities in the first treatment cycle, adverse events, and serious adverse events over up to three years. Researchers will measure objective tumor responses and other clinical outcomes such as duration of response, disease control rate, and progression-free survival. Safety monitoring includes regular evaluations and long-term follow-up to understand the treatment's impact on advanced solid tumors over time.

Researchers are investigating whether treatment with acyclovir improves survival in ventilated intensive care patients who have pneumonia and a high amount of herpes simplex virus (HSV) detected in their respiratory tract. HSV is commonly present in most people but usually remains inactive. In severely ill patients, especially those in intensive care on mechanical ventilation, HSV can reactivate and may cause serious infections. Previous retrospective studies suggested that antiviral treatment might improve survival, but these studies had biases and did not provide definitive evidence. This trial aims to clarify if treating HSV with acyclovir benefits these patients. The study is a phase 3, multicenter, randomized controlled trial involving 616 ICU patients on mechanical ventilation with pneumonia and HSV detected in bronchoalveolar lavage (BAL) fluid at levels of at least 10,000 copies/ml. Participants will be randomly assigned to receive either intravenous acyclovir at a dose of 10 mg/kg body weight every 8 hours for 10 days (or until ICU discharge if sooner) or no antiviral therapy. The goal is to compare outcomes between those treated with acyclovir and those not receiving antiviral therapy. During the study, participants will be monitored for survival status at 30 days as the primary outcome. Secondary outcomes include days free from ventilation and vasopressors up to 30 days, as well as safety assessments. The study involves detailed monitoring of the participants' condition in the ICU to evaluate the effects of acyclovir treatment on recovery and survival over the first month after enrollment.

Researchers are evaluating a combined approach using peer navigation and mobile health (mHealth) technology to increase the use of HIV, sexually transmitted infection (STI), and hepatitis C virus (HCV) prevention and care services among racially and ethnically diverse gay, bisexual men who have sex with men (GBMSM), and transgender women living in rural Appalachia. This study aims to address health disparities in these vulnerable and often overlooked populations by promoting culturally compatible, bilingual interventions. The research seeks to improve testing rates and overall health outcomes related to HIV, STI, and HCV in this community. The intervention includes two main strategies. Community health leaders act as peer navigators, raising awareness of HIV, STIs, and HCV prevention and care services within their social networks, holding at least four group sessions over 12 months. They also use preferred mHealth platforms such as Facebook, Instagram, and GPS-based apps to communicate with participants, plan activities, provide reminders, and support service use in real time. These combined strategies aim to encourage testing and use of care services. Participants will be monitored for HIV, STI, and HCV testing at baseline, immediately after the 12-month intervention, and again at a 12-month follow-up, 24 months post-baseline. Researchers will measure the number of participants undergoing these tests at each time point to assess the intervention's impact. The study involves ongoing communication and support through both in-person activities and digital platforms, with the total participation lasting at least two years from baseline testing through follow-up assessments.

Researchers are evaluating an intervention program designed to reduce risky sexual behaviors among college students aged 16 to 24. The program is based on the Behavior Change Wheel (BCW) theory and behavior change techniques (BCTs). It aims to improve psychosexual health, social support, sexual self-efficacy, risk perception, and decision-making abilities to decrease risky sexual activities and adverse outcomes in this population. The intervention targets risky sexual behaviors by combining literature analysis, qualitative research, expert correspondence, and a pre-experiment involving test and control groups of students. The study measures changes before the intervention (T0) and after 12 weeks (T1) in sexual mental health, social support, and sexual self-efficacy using relevant scales to monitor effectiveness. Participants will be assessed for their psychosexual health, social support levels, and sexual self-efficacy at the start and end of the 12-week intervention. Researchers track these outcomes to determine if the program successfully reduces risky sexual behaviors and improves related psychological and social factors. The study provides important insights for preventing risky sexual behaviors among college students.

Researchers are investigating different methods to detect recurrence in women diagnosed with vulva cancer to improve treatment and monitoring programs. This nationwide Danish study, called DaVulvaRec, will include 295 patients and combine patient-reported outcome measures with medical data to better understand symptoms and care during the course from initial disease to recurrence. The study also explores whether circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from these patients, aiming to enhance early detection of relapse. The study involves collecting liquid biopsies at the start and throughout follow-up to measure ctDNA levels. Patients will provide patient-reported outcomes every four months during surveillance, which may trigger telephone interviews with a nurse based on their responses. All patients will be followed for up to two years or until a recurrence is detected. A historical control group of 1000 vulva cancer patients diagnosed between 2011 and 2022 will be used for comparison. Participants will regularly complete questionnaires and provide blood samples to monitor disease status and late effects after treatment. The main outcomes measured are recurrence-free survival and overall survival over two years. This approach aims to detect residual disease early, guide additional treatment decisions, and improve monitoring for relapse and long-term effects in vulva cancer survivors.

Trigeminal herpetic neuralgia is a common form of Zoster-associated Pain (ZAP) that affects people of all ages and poses a significant burden worldwide. Researchers are conducting a randomized controlled trial to evaluate the effectiveness and safety of electroacupuncture (EA) for treating ZAP and to see if EA can be a substitute for pregabalin, a common medication used for this condition. This study aims to provide reliable evidence on these treatments for trigeminal herpetic neuralgia. The trial includes three groups: one receiving pregabalin medication, one receiving electroacupuncture, and a combined group receiving both treatments. The medication group takes 150 mg pregabalin capsules twice daily for 4 weeks. The EA group receives electrical stimulation at specific acupoints on the affected side for 30 minutes per session, with a frequency set at 2/100 Hz. The combined group receives both the pregabalin medication and the same electroacupuncture treatment concurrently. Participants will be assessed throughout the study at baseline and during treatment weeks 2 and 4, followed by follow-ups at weeks 8 and 16. Researchers will measure pain changes using a visual analog scale at these time points. Participants must be able to communicate clearly and consent to participate. Safety and treatment effects will be monitored, with a total study duration extending to 16 weeks from the start of treatment.

Researchers are evaluating the STRATICYTE1 predictive model to determine its ability to predict the progression of oral potentially malignant disorders (OPMDs) into oral squamous cell carcinoma (OSCC) by studying a group of patients who had biopsies in the past. The study aims to measure how sensitive and specific STRATICYTE1 is in identifying patients at risk, to explore factors that may affect its accuracy, and to understand the relationship between the STRATICYTE1 results and the time it takes for oral cancer to develop. Participants' archived biopsy samples from oral lesions are assessed using the STRATICYTE1 test to evaluate their risk of progression to oral cancer. The study involves patients who had clinically evident oral lesions with biopsy-proven dysplasia and either have at least five years of clinical follow-up without cancer or have developed OSCC. The test results and patient data are analyzed retrospectively to validate STRATICYTE1's predictive performance. During the study, researchers will review patient and clinical characteristics along with STRATICYTE1 test results to assess sensitivity and specificity over a five-year period. The primary outcomes include evaluating the accuracy of STRATICYTE1 in predicting cancer transformation and analyzing survival data for up to five years. This retrospective analysis helps identify how well the model predicts oral cancer development from high-risk oral lesions.