The United States of America, As Represented by the Secretary, Department of Health and Human Services

Johns Hopkins University

The United States of America As Represented by the Department of Health

Center for Disease Control and Prevention

William M Switzer

Walid M Heneine

Thomas M Folks

Donald S Burke

Nathan D Wolfe

Jennifer Brown

Paul Sandstrom

Shinji Yamamoto

Eitel Mpoudi Ngole

Chou-Pong Pau

Shambavi Subbarao

Margaret E Callahan

Paul A Sandstrom

Jan Pohl

Timothy Clyde Granade

Shanmugam Vedapuri

Aprille L Matthews

Gerardo Garcia Lerma

Gerardo Garcia-Lerma

Clement B Ndongmo

Marcia L Kalish

David M Sintasath

HaoQiang Zheng

Ae Saekhou Youngpairoj

Mpoudi Eitel

Disclosed are monoclonal antibodies that specifically bind emtricitabine (FTC). Methods are also disclosed for using these antibodies to detect FTC in samples. In some embodiments, these methods are of use for determining if a subject is complying with a therapeutic or prophylactic protocol. In other embodiments, methods are disclosed for determining the dose of FTC to administer to a subject.

Monoclonal antibody for the detection of the antiretroviral drug emtricitabine (FTC, 2',3&#x2032;-dideoxy-5-fluoro-3&#x2032;-thiacytidine)

Disclosed are compositions and methods related to the isolation and identification of the primate T-lymphotropic viruses, HTLV-3 and HTLV-4. The diversity of HTLVs was investigated among central Africans reporting contact with NHP blood and body fluids through hunting, butchering, and keeping primate pets. Herein it is shown that this population is infected with a variety of HTLVs, including two retroviruses; HTLV-4 is the first member of a novel phylogenetic lineage that is distinct from all known HTLVs and STLVs; HTLV-3 falls within the genetic diversity of STLV-3, a group that has not previously been seen in humans. The present disclosure also relates to vectors and vaccines for use in humans against infection and disease. The disclosure further relates to a variety of bioassays and kits for the detection and diagnosis of infection with and diseases caused by HTLV-3 and HTLV-4 and related viruses.

Primate T-lymphotropic viruses

Disclosed are the simian T-cell lymphotropic virus type 3 subtype D (STLV-3 subtype D), isolated nucleic acid molecules encoding STLV-3 subtype D polypeptides, such as STLV-3 subtype D envelope, protease, polymerase, tax, rex, and capsid polypeptides, isolated polypeptides encoded by such nucleic acids. Methods are also disclosed for detecting STLV-3 subtype D, for example by detecting a STLV-3 subtype D nucleic acid or polypeptide in the sample. Accordingly, probes, primers, and antibodies for use in detecting STLV-3 subtype D nucleic acids or polypeptides are disclosed. Therapeutic compositions which included isolated nucleic acid molecules encoding a STLV-3 subtype D polypeptides or isolated polypeptides encoded by such nucleic acid molecules are also disclosed.

Simian T-cell lymphotropic virus

A method for detecting at least one antibody directed against at least one primate immunodeficiency virus in a biological sample that includes contacting a biological sample with (i) at least one detection multiple antigenic peptide comprising a portion of an immunodominant region of a transmembrane protein of a primate immunodeficiency virus and (ii) at least one differentiation multiple antigenic peptide comprising a portion of a V3-loop of an envelope protein of a primate immunodeficiency virus. Also disclosed is an enzyme immunoassay that includes a first substrate to which are bound at least one of the detection multiple antigenic peptides and a second substrate to which are bound at least one of the differentiation multiple antigenic peptides.

Multiple antigenic peptide assay for detection of HIV or SIV type retroviruses

Assays and kits for the detection of phenotypic resistance of a retrovirus to reverse transcriptase inhibitor-drugs in a biological sample. The assays are based on the direct analysis of the susceptibility of retroviral reverse transcriptase to inhibition by a reverse transcriptase inhibitor drug. The enzymatic activity of the reverse transcriptase is determined by measuring the DNA product produced when an RNA template and a first complementary DNA primer from a suitable region of the encephalomyocarditis virus genome are incubated with a biological sample containing reverse transcriptase in the presence of the drug to which resistance is being determined. The DNA product is amplified and detection of the amplified DNA indicates resistance to the drug employed in the assay. Detection of relatively greater amounts of amplified DNA when certain drugs are used indicates the presence of multiple nucleoside analog resistant strains or mutations.

Method and kit for detecting resistance to antiviral drugs

The present invention comprises compositions and methods comprising a spumavirus isolated from a human. More specifically, the spumavirus of the present invention was isolated from a human who had exposure to nonhuman primates. Importantly, the methods and compositions of the present invention comprising the spumavirus and including antibodies to the spumavirus, can be used to detect the presence of spumavirus or antibodies in body fluids, for pathogenicity studies of related viruses, and as a vector for gene therapies. The present invention can also be used for treatment of conditions in humans due to the presence of rapidly dividing cells and for recombinant live virus vaccination.

Isolation of a human retrovirus

An assay and kit for the detection of phenotypic resistance of a retrovirus to a reverse transcriptase inhibitor drug in a biological sample. The assay is based on the direct analysis of the susceptibility of retroviral reverse transcriptase to inhibition by a reverse transcriptase inhibitor drug. The enzymatic activity of the reverse transcriptase is determined by measuring the DNA product produced when an RNA template and a first complementary DNA primer from a suitable region of the encephalomyocarditis virus genome are incubated with a biological sample containing reverse transcriptase in the presence of the drug to which resistance is being determined.

The present invention comprises spumavirus isolated from humans. More specifically, the spumavirus of the present invention was isolated from humans who had exposure to nonhuman primates. Importantly, the spumavirus of the present invention or antibodies to the spumavirus can be used to detect the presence of spumavirus or antibodies in body fluids, for pathogenicity studies of related viruses, and as a vector for gene therapies. The spumavirus of the invention can also be used for treatment of conditions in humans due to the presence of rapidly dividing cells and for recombinant live virus vaccination.

Retrovirus isolated from humans

The present invention comprises a spumavirus isolated from a human. More specifically, the spumavirus of the present invention was isolated from a human who had exposure to nonhuman primates. Importantly, the spumavirus of the present invention or antibodies to the spumavirus can be used to detect the presence of spumavirus or antibodies in body fluids, for pathogenicity studies of related viruses, and as a vector for gene therapies. The spumavirus of the invention can also be used for treatment of conditions in humans due to the presence of rapidly dividing cells and for recombinant live virus vaccination.

Spumavirus isolated from humans

The present invention comprises methods, devices and compositions for detection of endogenous retroviruses found in xenotransplant materials. The methods and compositions are suited for detection of endogenous type-C retroviruses and in particular, for porcine endogenous retrovirus, PERV.

Method and composition to detect C-type retroviral infection

Compositions, methods and diagnostic devices for monitoring graft integrity in xenotransplantation and for detecting infectious agents transmitted by the xenograft are described. In particular, the compositions, methods and devices are useful for determining porcine xenograft integrity and persistence and can detect the presence of PERV (porcine endogenous retrovirus) in a biological sample. The compositions, methods and devices are useful for determining or monitoring graft survival and rejection in recipients of xenografts and are useful for detecting the presence of pig cell and PERV infection in a xenotransplant recipient or donor. In addition, the compositions, methods and devices are useful for screening therapeutic products to be administered to humans to ensure that the products are free of pig cells, and thus free of PERV contamination, prior to administration.

Methods and devices for detection of xenogeneic graft persistence and infectious agents

The present invention provides a method for detecting the presence of a retrovirus in a biological sample comprising the steps of: a) contacting the biological sample with an RNA template and a complementary DNA primer under conditions whereby the RNA template and the DNA primer will anneal and a DNA strand will be synthesized as an extension from the DNA primer if reverse transcriptase is present in the sample; b) amplifying the synthesized DNA; and c) detecting the amplification of the synthesized DNA, the amplification of the synthesized DNA indicating the presence of reverse transcriptase in the biological sample, thus indicating the presence of a retrovirus in the biological sample.

Growing community of inventors

Stone Mountain, GA, United States of America

William M Switzer