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Adenoviridae Infections clinical trials

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NCT ID: NCT03532035 Withdrawn - Adenovirus Clinical Trials

Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia

Start date: December 15, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized, controlled, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and 11) or to receive investigator-assigned standard of care (SoC).

NCT ID: NCT03029871 Withdrawn - Clinical trials for Non-small Cell Lung Cancer Stage I

Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer

NSCLC
Start date: January 13, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this phase 1 trial is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic gene therapy in combination with SBRT in medically inoperable stage I/IIA (T1A - T2B) NSCLC. To accomplish this objective, 9 subjects will be enrolled in the study. We hypothesize that the combined treatment will demonstrate acceptable toxicity, and that it will be feasible to quantify adenovirus-mediated HSV-1 TK gene expression in the lung by PET. This phase 1 trial will lay the foundation for a follow-up phase 2 trial designed to examine efficacy.

NCT ID: NCT02702427 Withdrawn - Clinical trials for Cytomegalovirus Infection

Virus-specific ImmunoTherapy Following Allogeneic Stem Cell Transplantation

VISIT
Start date: August 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are treated with virusspecific donor derived or autologous virusspecific T-cells.

NCT ID: NCT02276820 Withdrawn - Clinical trials for Adenovirus Infection

Most Closely Human Leukocyte Antigen (HLA)-Matched Adenovirus-specific T Lymphocytes (Viralym-A)

Start date: December 7, 2017
Phase: Phase 1
Study type: Interventional

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. Adenovirus (AdV) is a virus that just causes symptoms of a common cold normally, but which can cause serious life-threatening infections in patients who have weak immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the pancreas and the eyes. Investigators want to see if they can use a kind of white blood cell called T cells to treat adenovirus infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated AdV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target AdV. In this study, investigators want to find out if the banked AdV-specific T cells derived from healthy donors are safe and can help to treat adenoviral infection. The AdV-specific T cells (Viralym-A) are an investigational product not approved by the Food and Drug Administration (FDA). Funding source - FDA OOPD

NCT ID: NCT01584037 Withdrawn - Adenovirus Clinical Trials

Adenovirus Vaccine Pregnancy Registry

Start date: December 2011
Phase: N/A
Study type: Observational [Patient Registry]

The primary purpose of the Adenovirus Vaccine Pregnancy Registry is to prospectively collect data concerning: 1. Pregnant women exposed to Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, 2. Potential confounding factors, and 3. The outcome of these pregnancies. The secondary purpose of the Adenovirus Vaccine Pregnancy Registry is to evaluate the frequency of birth defects in prospectively enrolled pregnant women. This Registry is also designed to detect any unusual patterns of birth defects.

NCT ID: NCT00448994 Withdrawn - Adenovirus Clinical Trials

Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

Start date: March 2007
Phase: N/A
Study type: Observational

This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased cells. The study will be conducted in children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing stem cell transplantation are more likely to develop infections as their immune systems are weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will participate for up to 1 year following the transplant procedure.