Clinical Trials Logo

HTLV-I Infections clinical trials

View clinical trials related to HTLV-I Infections.

Filter by:
  • Completed  
  • Page 1 ·  Next »

NCT ID: NCT03829709 Completed - HTLV-I Infections Clinical Trials

Electromiography Study in the Respiratory Muscle Training in Human Lymphotropic Virus Type 1

Start date: January 30, 2019
Phase: N/A
Study type: Interventional

The main objective of the research will be to analyze, through surface electromyography, the impact of inspiratory muscle training before a supervised home training protocol in patients with human T-cell lymphotropic virus type 1 (HTLV-1). For this, a clinical, longitudinal, prospective, quantitative and single center trial will be carried out, aiming at home inspiratory muscle training lasting 5 weeks, 3 times a week, 30 minutes daily through the IMT Threshold, with 14 volunteers enrolled in the Laboratory of Studies in Functional Rehabilitation (LAERF) of the Federal University of Pará (UFPA). They will be classified as the manifestation of Tropical Spastic Paraparesis / Myelopathy (PET / MAH) for GP (PET / MAH probable) and GD (PET / MAH definitive) groups, obeying inclusion criteria. For characterization of expiratory flow rates and flows, as well as respiratory muscle strength, they will be submitted to spirometry and manovacuometry, pre, per, and post treatment, respectively. For the analysis of the electromyographic activity, the diaphragm, parasternal and sternocleidomastoid muscles will be counted in the follow-up during the analysis of inspiratory muscle strength, as well as once a week during the conduction of the inspiratory muscle training protocol. The collected data will be stored in a Microsoft Office Excel® 2010 worksheet and then submitted to statistical analysis using the Bioestat 5.0® program, adopting a standard error of 5%. The theoretical support of the research will have a bibliographical survey of scientific articles collected during the design of the project, and the accomplishment of the research. It is expected to map, through the surface electromyographic study, the impact of respiratory muscle training at a distance on the inspiratory muscle strength of patients with HTLV-I virus with probable or definitive PET / MAH.

NCT ID: NCT03226119 Completed - HTLV-I Infections Clinical Trials

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

NCT ID: NCT03146013 Completed - HTLV-I Infections Clinical Trials

Dual Algorithm Post Market Clinical Study

Start date: March 1, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

NCT ID: NCT02655471 Completed - Clinical trials for Tropical Spastic Paraparesis

Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection

Start date: July 1, 2017
Phase: Early Phase 1
Study type: Interventional

This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients.

NCT ID: NCT02631746 Completed - Clinical trials for Adult T-Cell Leukemia/Lymphoma

Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma

Start date: February 21, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well nivolumab works in treating patients with human T-cell leukemia virus (HTLV)-associated T-cell leukemia/lymphoma. Nivolumab is an antibody, which is a type of blood protein that tags infected cells and other harmful agents. Nivolumab works against a protein called programmed cell death (PD)-1 and may help the body destroy cancer cells by helping the immune system to keep fighting cancer.

NCT ID: NCT01867320 Completed - HTLV-I Infection Clinical Trials

Raltegravir for HAM/TSP

Start date: September 5, 2013
Phase: Early Phase 1
Study type: Interventional

Background: - Human T-cell lymphotropic virus type 1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) is an infection of the spinal cord. The infection is caused by a virus that has been known to cause cancers like leukemia and lymphoma. It causes a weakening of the legs. Researchers want to see if raltegravir, a drug for treating human immunodeficiency virus (HIV), can be used to treat HAM/TSP. They will see if the drug can reduce the amount of virus in the blood of people with HAM/TSP. Objectives: - To see if raltegravir can reduce the viral load of people with HAM/TSP. Eligibility: - Individuals at least 18 years of age who have HAM/TSP. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected. Imaging studies will be performed. A lumbar puncture will also be taken. - Participants will take the study drug twice a day for 6 months. They will note each dose in a study diary, as well as any side effects. - At the 6-month visit, participants will stop taking the study drug. They will have a physical exam and blood samples, as well as other tests. - Participants will have two further exams 9 months and 15 months after starting the study drug. They will have a physical exam and blood samples, as well as other tests.

NCT ID: NCT01754311 Completed - HTLV-I Infections Clinical Trials

Influence of IL28B Genetic Variation on the Phenotype Infection of HTLV-1

HAMIL28B
Start date: May 13, 2013
Phase:
Study type: Observational

Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM have a HTLV-1 proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic. Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its rapid evolution is partly attributed to the failure of the immune system that regulates viral replication and expression. It has recently been shown that different versions of Single Nucleotide (human leukocyte antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced the severity of infection with hepatitis C and effectiveness of treatment. By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT genotype was statistically more frequent in the group TSP / HAM than in asymptomatic patients (80% versus 20%) and was associated with HTLV-1 proviral load higher. We propose a broader group of patients in our population and Afro-Caribbean, to confirm the results of the latter study was conducted in a predominantly Latin American population.

NCT ID: NCT01581567 Completed - Multiple Sclerosis Clinical Trials

Neuroimmunology Branch Repository

Start date: July 15, 2011
Phase:
Study type: Observational

Background: - Information and samples collected from participants in medical research studies can be useful even after the original study is complete. Researchers can use the information and samples to learn more about multiple sclerosis or other immune system disorders. They can also be used for research into other disorders. Researchers would like to get permission to use samples collected from older studies to launch new lines of research. Objectives: - To look at information and samples from earlier National Institutes of Health Neuroimmunology Branch studies. Eligibility: - People who provided samples and medical information for earlier studies. Design: - Researchers will contact people who took part in earlier studies. Researchers will ask if they can study previously collected data and samples. - Data and samples may include physical exam data and psychological test results. Imaging study results are included. Preserved samples of body fluids and tissues may be studied. These include blood and urine samples. - No new treatment will be provided as part of this research study.

NCT ID: NCT00001941 Completed - HTLV-I Infection Clinical Trials

Anti-Tac for Treatment of Leukemia

Start date: December 1999
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD) of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult T-cell leukemia/lymphoma (ATL); (2) to define the dose of Zenapax(Registered Trademark) required to saturate interleukin 2 receptor alpha (IL-2R) alpha in patients with ATL; (3) determine the clinical response to humanized (Hu) anti-Tac (Zenapax(Registered Trademark) of patients with Tac-expressing adult T-cell leukemia; and (4) determine the serum dieaway curve (pharmacokinetics) of infused humanized (Hu)-anti-Tac in patients who have ATL. This study represented an extension of Metabolism Branch National Cancer Institute (NCI) protocols utilizing modifications of the original murine anti-Tac monoclonal antibody (mAb) developed by our group for the treatment of ATL. The scientific basis for these therapeutic studies is that the leukemic cells of patients with ATL express abnormally high levels of the Tac antigen (IL-2R alpha) on their surface whereas resting normal cells including normal T-cells of the patients do not. One presumed mode of action of Hu-anti-Tac in the treatment of ATL involves the interruption of the interaction of interleukin 2 (IL-2) with its growth factor receptor. To be effective in this goal we must maintain saturation of the IL-2 receptors (IL-2R) with humanized anti-Tac thereby preventing IL-2 mediated proliferation and yielding cytokine deprivation and apoptotic cell death of the leukemic cells. Eligible patients with ATL were treated with escalating doses of Zenapax(Registered Trademark) between groups in the Clinical Center of the National Institutes of Health (NIH). Groups of patients received sufficient Zenapax(Registered Trademark) to yield saturation of the IL-2 receptor for a period of 17 weeks. Clinical response was evaluated using routine immunological and clinical evaluation and by monitoring the saturation of the IL-2R and the absolute number of residual circulating malignant cells by fluorescence activated cell sorting (FACS) analysis using two fluorochrome-labeled non-crossreacting antibodies to the IL-2 receptor, anti-Tac and 7G7/B6, as well as antibodies to cluster of differentiation 3 (CD3), cluster of differentiation 4 (CD4), cluster of differentiation 7 (CD7), and cluster of differentiation 8 (CD8). Furthermore, responses were evaluated in patients with leukemia by Southern blot analysis of the arrangement of the T-cell receptor genes and human T-lymphotropic virus type 1 (HTLV-I) integration. Finally, in select patients, to define the pharmacokinetics of the therapeutic antibody, had planned to monitor the serum levels of the infused Hu-anti-Tac (Zenapax(Registered Trademark)) as a function of time. This study is an essential element of our program involving IL-2R-directed therapeutic studies. If as anticipated the therapy with humanized anti-Tac yields some partial and complete remissions in patients with ATL, we will propose that it be used as a single agent for patients with smoldering and chronic ATL and in association with chemotherapeutic agents to provide a novel approach for the treatment of acute and lymphoma forms of ATL. We also plan a future clinical trial where tentative plans also had been made to evaluate the efficacy and toxicity in ATL patients of saturating doses of Zenapax(Registered Trademark) as compared to identical doses of Zenapax(Registered Trademark) given in association with (90)Y-armed 7G7/B6, a non-competing antibody to IL-2R alpha or in combination with chemotherapy.

NCT ID: NCT00001785 Completed - Clinical trials for Tropical Spastic Paraparesis

Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)

Start date: September 1998
Phase: Phase 2
Study type: Interventional

HTLV stands for human T cell leukemia virus. HTLV-1 is a virus that attacks specific kinds of white blood cells called T cells. T cells are part of the natural defense system of the body. HTLV-1 has been associated with leukemia and lymphoma. In addition, approximately 1% of all patients infected with HTLV-1 develops a condition known as HTLV-1 associated myelopathy (HAM) / tropical spastic paraparesis (TSP). Currently there is no clearly defined, effective treatment for patients with HAM/TSP. Steroids have been used as therapy but have only been able to provide temporary relief of symptoms. Human interferon is a small protein released from different kinds of cells in the body. Interferon has been known to have antiviral and immunological effects and has been used to treat hepatitis and multiple sclerosis. Interferon Beta is released from cells called fibroblasts. These cells play a role in the production of connective tissue. The purpose of this study is to evaluate the possible role of recombinant interferon beta (Avonex) in treatment of HAM/TSP. The study is broken into three phases, a pre-treatment phase, a treatment phase, and a post-treatment phase. The total duration of the study will be 44 weeks. Patients participating in this study will receive injections of Avonex 1 to 2 times a week. Throughout the study patients will regularly submit blood samples and undergo diagnostic tests such as MRI and measures of somatosensory evoked potentials.