Newark

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating whether combining HIV-specific broadly neutralizing antibodies bNAbs with antiretroviral therapy ART in adults newly diagnosed with acute HIV infection AHI is safe and can delay viral rebound compared to ART alone. This phase II, randomized, double-blind, placebo-controlled study aims to assess the impact of this combination on viral load, immune response, and viral reservoirs. The study is sponsored by the National Institute of Allergy and Infectious Diseases NIAID. Participants are randomly assigned to receive either a combination of two bNAbs, VRC07-523LS and PGT121.414.LS, given as intravenous infusions once at study entry alongside daily oral ART, or a placebo infusion with daily ART. The study involves several steps, including treatment initiation, analytic treatment interruption, and monitoring phases. The bNAbs are administered intravenously at specific doses over 15 to 60 minutes at enrollment. ART consists of a daily oral tablet containing bictegravir, emtricitabine, and tenofovir alafenamide. During the study, participants attend scheduled visits for safety assessments, blood tests measuring viral load and immune cells, and monitoring for side effects or adverse events. Researchers track the time to viral rebound after stopping ART, changes in immune cell counts, and drug levels in the blood. Participants who meet criteria for restarting ART will do so and continue to be monitored. The total participation includes treatment and follow-up periods, with close observation to evaluate safety and treatment effects up to 24 weeks after ART interruption.

The trial investigates the use of EscharEx, a proteolytic enzyme gel, compared to a placebo gel in treating venous leg ulcers VLU in adults. The goal is to evaluate how well EscharEx works and how safe it is for removing dead tissue debridement and preparing the wound bed for healing. This study involves adult patients who have VLUs with specific size and duration criteria. Participants will be randomly assigned to receive either EscharEx EX-03 5% formulation or a placebo gel. The treatment involves applying a gel made by mixing a sterile powder with water to the wound area. The study lasts up to 29 weeks and includes several phases a screening period, up to 8 daily visits for debridement within 2 weeks, weekly wound management visits for up to 12 weeks including wound closure confirmation, and monthly visits over 12 weeks to monitor wound closure durability. During the study, patients will undergo regular clinical assessments of the wound, including visual checks for complete debridement and wound closure, as well as evaluations of healthy tissue growth. The study measures the time taken for complete wound closure and the presence of healthy tissue. Safety and wound healing progress are closely monitored throughout the treatment and follow-up periods, ensuring adherence to the protocol and proper wound management.

Researchers are evaluating zanidatamab combined with chemotherapy for treating people with HER2-positive, early-stage breast cancer. This phase 2 study aims to assess the safety and effectiveness of this combination compared to standard treatments in participants with newly diagnosed stage II or III invasive breast carcinoma. Participants are randomly assigned to one of three treatment groups zanidatamab with paclitaxel, zanidatamab with docetaxel and carboplatin, or trastuzumab and pertuzumab with docetaxel and carboplatin. All study drugs are administered intravenously. After neoadjuvant therapy, participants will undergo either mastectomy or breast conserving surgery as decided by their physician. During the study, participants will have their response to treatment assessed through measurements such as pathologic complete response and residual cancer burden classification up to 8 months. Safety is monitored by tracking treatment-related adverse events up to 23 months. Other assessments include survival outcomes up to 46 months and serum concentrations of zanidatamab. The study participation may last several years to capture these outcomes.

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

This trial focuses on patients with stage IV pressure ulcers complicated by osteomyelitis. It aims to evaluate the safety, tolerability, and the difference in effects between a new treatment called STIMULAN VG combined with debridement and systemic antibiotics, versus the standard care involving debridement and systemic antibiotics alone. The study is a phase II, open-label, randomized, multi-center trial designed to compare these approaches in treating this condition. Participants are randomly assigned to one of two groups one receives ulcer bursectomy, debridement, insertion of STIMULAN VG into the ulcer cavity, followed by flap or primary closure and peri-operative antibiotics the other group receives the standard care consisting of ulcer bursectomy, debridement, flap or primary closure, and peri-operative antibiotics without STIMULAN VG. The trial evaluates treatment over an 8-week period post-operation. During the study, participants will undergo assessments to determine individual patient success and clinical outcomes at the 8-week follow-up visit. Researchers will monitor safety and tolerability throughout the trial, with evaluations including imaging to confirm osteomyelitis and clinical status related to wound healing. Participants are expected to comply with scheduled visits, treatment plans, and study procedures for the duration of the trial.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with advanced urothelial cancer that has spread locally or to other parts of the body. This phase III trial focuses on patients whose cancer has not responded to prior anti-PDL1 therapy. The study aims to compare overall survival, progression-free survival, response rates, duration of response, treatment side effects, and quality of life between the new combination therapy and usual chemotherapy care. Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in 21-day cycles for up to six cycles or until disease progression or unacceptable side effects. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 every 21 days for up to 35 cycles or two years, unless disease progresses or side effects become unacceptable. Both groups undergo blood tests and imaging scans like CT or MRI throughout the study. During the trial, participants will have regular assessments including blood sample collection and imaging to monitor their cancer status and treatment effects. Researchers will also evaluate patient-reported quality of life and fatigue at multiple time points up to 12 months. After completing treatment, participants are followed up 30 days later and then annually for five years to track survival and health outcomes. This comprehensive approach helps researchers understand both the clinical outcomes and the impact on patients well-being over time.

Researchers are investigating the best way to combine chemotherapy and radiation therapy for patients aged 3 to 29 years with localized non-germinomatous germ cell tumors NGGCT in the brain. This phase II trial aims to optimize treatment based on how well the tumor responds to initial chemotherapy, with the goal of reducing spinal cord relapses and adjusting therapy for better disease control. The study also compares different radiation types and examines cognitive and physical effects in children and young adults with NGGCT. Participants first receive induction chemotherapy consisting of carboplatin, etoposide, and ifosfamide over six cycles every 21 days. Based on tumor response, patients are assigned to one of two plans Plan A involves whole ventricular plus spinal canal irradiation WVSCI, delivered daily for 6 weeks, while Plan B includes high-dose chemotherapy with stem cell transplant followed by radiation therapy to the whole brain and spine. Some patients may undergo second-look surgery depending on tumor response before continuing treatment. Throughout the study, participants undergo MRI scans, collection of cerebrospinal fluid and blood samples, and questionnaires assessing cognitive, social, and behavioral functioning. Researchers monitor tumor response, progression-free survival, overall survival, and patterns of disease recurrence for up to 10 years. Safety and side effects are also evaluated to better understand long-term outcomes of these treatment approaches.

Researchers are evaluating how well combination chemotherapy works in treating patients with newly diagnosed stages 2 to 4 diffuse anaplastic Wilms tumor DAWT and patients with relapsed favorable histology Wilms tumor FHWT. This phase II trial compares the effects of two chemotherapy regimens, UH-3 and ICECycloTopo, on event-free survival and overall survival, aiming to improve outcomes based on different relapse risk groups and prior treatments. The study also explores kidney toxicity, genetic markers, surgery impacts, and radiation therapy techniques to reduce side effects and better understand tumor behavior. Participants are assigned to one of two treatment groups. In Arm I Regimen UH-3, patients receive cycles of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan intravenously over various days in a 21-day cycle, with radiation therapy at week 7 of cycle 3 if needed. In Arm II Regimen ICECycloTopo, patients receive cycles of carboplatin, etoposide, ifosfamide, cyclophosphamide, and topotecan intravenously over 10 cycles every 21 days, with surgery andor radiation therapy during certain cycles as clinically indicated. Throughout the trial, patients undergo multiple imaging tests including CT scans, PET scans, chest x-rays, MRIs, abdominal ultrasounds, and bone scans, along with blood sample collections and biopsies. After completing treatment, follow-up visits occur every 3 months for the first 2 years, then every 6 months for years 3 and 4, and once at year 5. The main outcomes measured are event-free survival and overall survival up to 5 years from study entry, with ongoing monitoring for treatment effects and safety.