Infections

All Conditions

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Symptoms and General Pathology

Immune System Diseases

Rare Diseases

Leukemia

Communicable Diseases

Leukemia, T-Cell

Virus Diseases

Leukemia-Lymphoma, Adult T-Cell

Lymphoma

Leukemia, Lymphoid

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Adult T-cell Leukemia/lymphoma

Human T-cell Leukemia Virus Type 1

Leukemia, T-cell, Chronic

Lymphosarcoma

Anti-Infective Agents

All Drugs and Chemicals

Raltegravir Potassium

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Integrase Inhibitors

HIV Integrase Inhibitors

Enzyme Inhibitors

Raltegravir

Lee Ratner, MD PhD

This is a study of the effect of raltegravir on human T-cell leukemia virus type 1 (HTLV-1) viral load in asymptomatic patients. The study will enroll 14 subjects for a period of 2 months of treatment and 1 month of followup. The study will assess the effect of raltegravir on virus load in peripheral blood lymphocytes, level of virus gene expression, and sites of viral integration.

About 5% of HTLV-1 infected individuals develop lymphoma or myelopathy. High levels of virus replication are predictive of disease development. HTLV-1 exhibits lower levels of variation than HIV-1, suggesting that drug resistance is less likely to occur. Raltegravir was shown to inhibit HTLV-1 integration and replication in culture using concentrations achievable with the approved dose used in HIV-1 infected patients. Currently, no treatment is recommended for asymptomatic infected individuals.

Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

Measured by DNA PCR from peripheral blood mononuclear cell DNA at days 0, 1, 8, 15, 29, 43, and 56.

Measured by real time PCR with DNA from sorted peripheral blood mononuclear cell DNA at days 1, 8, 15, 29, 43, and 56.

1. Number of LTR circles measure by real time PCR on peripheral blood mononculear cell DNA at days 0, 1, 8, 15, 29, 43, and 56
2. Level of Proviral RNA Expression in PBMCs measured by real time RT PCR on peripheral blood mononculear cell RNA at days 0, 1, 8, 15, 29, 43, and 56

Measured by automated sequence analysis of PCR amplified viral DNA obtained at days 0, 1, 8, 15, 29, 43, and 56

Measured by automated DNA analysis of oligonucleotide linked PCR amplified DNA from peripheral blood mononuclear cell DNA obtianed at days 0, 1, 8, 15, 29, 43,and 56

Assessed by physical exam, CBC, and serum chemistries on days 29 and 57 and

Merck Sharp & Dohme LLC

Washington University School of Medicine

Nervous System Diseases

Musculoskeletal Diseases

Bone Marrow Diseases

Paraparesis, Tropical Spastic

HTLV-I Infections

HTLV-II Infections

Muscle Spasticity

Paraparesis

Spinal Cord Diseases

Disease Attributes

Central Nervous System Diseases

Myelitis

Central Nervous System Infections

Retroviridae Infections

RNA Virus Infections

Neuroinflammatory Diseases

Syndrome

Immunologic Deficiency Syndromes

HTLV-1 Associated Myelopathy/tropical Spastic Paraparesis

Human T-cell Leukemia Virus Type 2

Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)

Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica

HTLV I/II Confirmation and Differentiation

MP Diagnostics HTLV Blot 2.4

Sara Dionne, PhD

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).

The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens

Clinical Sites and the Reference Core-Lab will be masked of specimen disease state

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens

All clinical study data will be compiled and shared with investigators following database lock.

MP Biomedicals Asia Pacific Pte. Ltd.

MP Biomedicals, LLC

Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay

Susan Stramer, Ph.D

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).

This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Dual Algorithm Post Market Clinical Study

Evaluation of the MP Diagnostics HTLV Blot 2.4

Individual patient data (IPD) was deidentified prior to sharing.

HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.

Blood donor specimens that tested non-reactive by previously licensed HTLV screening assay.

Blood donor specimens that tested repeat reactive by previously licensed HTLV screening assay, but are unconfirmed.

Blood donor specimens that tested repeat reactive with a licensed HTLV screening assay and have been confirmed through additional, unlicensed supplemental testing.

Supplemental testing algorithm performed by the CDPHL.

CDPHL Algorithm

The purpose of this study is:

1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.

This is a retrospective study designed to assess the validity and reproducibility of the MP Diagnostics IVD device, the HTLV Blot 2.4 (MP Blot), in various populations. The study will be conducted at three geographical distinct locations.

The validity of the MP Blot will be assessed by calculating the following:

1. Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
2. Percent positive agreement with CDPHL Algorithm on 200 EIA repeat reactive specimens

The sensitivity of the MP Blot will be evaluated by testing 200 known positive specimens. The study will be performed using three product lots at three clinical sites.

The reproducibility of the MP Blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load	NCT01620736	Human T-cell Le...	Raltegravir	18 Years -	Washington University School of Medicine
Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load	NCT01620736	Human T-cell Le...	Raltegravir	18 Years -	Washington University School of Medicine
MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study	NCT03226119	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	MP Diagnostics ...	18 Years -	MP Biomedicals, LLC
Dual Algorithm Post Market Clinical Study	NCT03146013	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	MP Diagnostics ...	18 Years -	MP Biomedicals, LLC
Evaluation of the MP Diagnostics HTLV Blot 2.4	NCT01467024	HTLV-I Infectio... HTLV-II Infecti... Human T-lymphot... Human T-lymphot... HTLV I Associat... HTLV I Associat...	CDPHL Algorithm	18 Years -	MP Biomedicals, LLC

Spots Global Cancer Trial Database for htlv

Every month we try and update this database with for htlv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for htlv

Every month we try and update this database with for htlv cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for htlv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.