News Briefs
News Briefs
Researchers at The Children's Hospital, Los Angeles (CHLA), began a phase 1 clinical trial to determine whether gene therapy is effective in treating children infected with HIV-1. The study will examine children between the ages of 3 and 13 years with HIV-1 infection who are currently being treated at CHLA.
Samples of the patients' bone marrow will be collected and processed to isolate the stem cells. A disabled mouse virus will be used to carry an anti-HIV-1 gene into the stem cells. Five days after collection, the stem cells will be given back to the patients intravenously. Follow-up blood tests will be performed over 2 years to look for evidence of successful insertion of the anti-HIV-1 gene into the stem cells, which form blood T cells, and to look for side effects from the procedure.
The primary objective of the trial is to evaluate the safety of the procedure. Secondary goals are to determine whether the anti-HIV-1 gene can be successfully transferred into the patients' stem cells and whether that, in turn, protects T lymphocytes from being eliminated by HIV-1.
The HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA) is actively recruiting new members. HIVMA was formed last fall to provide a forum for physicians, scientists, and other health care professionals dedicated to the field of HIV/AIDS, not just those trained in infectious diseases. More than 750 members already have joined, making HIVMA the largest
organization representing HIV/AIDS physicians in the United States.
Those eligible to join HIVMA include clinicians, educators, and researchers whose primary professional activities involve HIV/AIDS medicine. The scope of activities for the new organization will be determined by the membership and elected board. The organization will make use of the membership and administrative infrastructure of the IDSA, including its HIV Quality Care Network, which focuses on defining appropriate standards of care for people living with HIV disease and examining Medicaid reimbursement policies. HIVMA members receive subscriptions to the Journal of Infectious Diseases and Clinical Infectious Diseases as well as discounts to IDSA's Annual Meeting, which will have an expanded HIV agenda. IDSA's HIV/AIDS Committee is conducting the initial development work for HIVMA.
For additional information, call (703) 299-1215, or visit the IDSA Web site, available at: http://www.idsociety.org.
Cytran Inc of Kirkland, Wash, is seeking participants to take part in a clinical trial of its experimental cancer drug, IM862. A total of 200 patients with AIDS-related Kaposi sarcoma are being sought to participate in a multinational, randomized, placebo-controlled, double-blind phase 3 study to assess the safety and efficacy of IM862. The trial will be conducted in collaboration with the AIDS Malignancy Consortium of the National Cancer Institute. US trial sites can be found in New York, Los Angeles, San Francisco, Seattle, San Diego, Chicago, Boston, Miami, Cleveland, Baltimore, Columbus, Philadelphia, St Louis, Nashville, and Newark. International cities include Toronto, Vancouver, Montreal, Ottawa, Brussels, Melbourne, and Sydney.
Preclinical research suggests that IM862's anticancer properties include inhibition of angiogenesis and stimulation of the immune system. Patients will be randomized to receive either IM862 or placebo and will self-administer treatments by placing a few drops of IM862 solution or placebo into the nose every other day. Patients will be seen every 4 weeks for evaluation of response and toxicity. Key patient eligibility criteria include HIV infection, biopsy-proven Kaposi sarcoma with 5 or more measurable lesions, stable on antiretroviral therapy for at least 8 weeks, and no symptomatic visceral disease. Study duration is 6 months. Patients on placebo who experience disease progression or have stable disease at the end of the study will be offered continued IM862 treatment. Patients who have responded to the first 6 months of treatment may continue on blinded treatment.
Prospective patients should call (800) 818-0980. Information on the study is also available at the AIDS Clinical Trials Information Service Web site, found at http://www.actis.org/
Virax Holdings Limited received ethics committee approval to start a clinical trial of a vaccine (VIR201) to treat people recently infected with HIV and will now begin patient recruitment. The trial, to be conducted in Melbourne and Sydney, Australia, will be a controlled, multicenter, double-blind, randomized, parallel group study in 36 patients to evaluate Virax's Co-X-Gene with fowlpox virus (FPV) technology. It is designed to evaluate the safety of the VIR201 vaccine and its ability to enhance killer T cells in early-stage HIV patients. The study will be conducted in association with the National Centre in HIV Epidemiology and Clinical Research.
VIR201 is a live viral vector vaccine that uses FPV to carry genes from the HIV virus and a human cytokine to cells in the body in order to trigger a directed immune response. Patients will receive a series of injections and be closely monitored over 12 months. If the trial shows the predicted immune response, Virax may seek an international biopharmaceutical partner to fund larger, later-stage studies to show its effectiveness.
Researchers at The Children's Hospital, Los Angeles (CHLA), began a phase 1 clinical trial to determine whether gene therapy is effective in treating children infected with HIV-1. The study will examine children between the ages of 3 and 13 years with HIV-1 infection who are currently being treated at CHLA.
Samples of the patients' bone marrow will be collected and processed to isolate the stem cells. A disabled mouse virus will be used to carry an anti-HIV-1 gene into the stem cells. Five days after collection, the stem cells will be given back to the patients intravenously. Follow-up blood tests will be performed over 2 years to look for evidence of successful insertion of the anti-HIV-1 gene into the stem cells, which form blood T cells, and to look for side effects from the procedure.
The primary objective of the trial is to evaluate the safety of the procedure. Secondary goals are to determine whether the anti-HIV-1 gene can be successfully transferred into the patients' stem cells and whether that, in turn, protects T lymphocytes from being eliminated by HIV-1.
The HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA) is actively recruiting new members. HIVMA was formed last fall to provide a forum for physicians, scientists, and other health care professionals dedicated to the field of HIV/AIDS, not just those trained in infectious diseases. More than 750 members already have joined, making HIVMA the largest
organization representing HIV/AIDS physicians in the United States.
Those eligible to join HIVMA include clinicians, educators, and researchers whose primary professional activities involve HIV/AIDS medicine. The scope of activities for the new organization will be determined by the membership and elected board. The organization will make use of the membership and administrative infrastructure of the IDSA, including its HIV Quality Care Network, which focuses on defining appropriate standards of care for people living with HIV disease and examining Medicaid reimbursement policies. HIVMA members receive subscriptions to the Journal of Infectious Diseases and Clinical Infectious Diseases as well as discounts to IDSA's Annual Meeting, which will have an expanded HIV agenda. IDSA's HIV/AIDS Committee is conducting the initial development work for HIVMA.
For additional information, call (703) 299-1215, or visit the IDSA Web site, available at: http://www.idsociety.org.
Cytran Inc of Kirkland, Wash, is seeking participants to take part in a clinical trial of its experimental cancer drug, IM862. A total of 200 patients with AIDS-related Kaposi sarcoma are being sought to participate in a multinational, randomized, placebo-controlled, double-blind phase 3 study to assess the safety and efficacy of IM862. The trial will be conducted in collaboration with the AIDS Malignancy Consortium of the National Cancer Institute. US trial sites can be found in New York, Los Angeles, San Francisco, Seattle, San Diego, Chicago, Boston, Miami, Cleveland, Baltimore, Columbus, Philadelphia, St Louis, Nashville, and Newark. International cities include Toronto, Vancouver, Montreal, Ottawa, Brussels, Melbourne, and Sydney.
Preclinical research suggests that IM862's anticancer properties include inhibition of angiogenesis and stimulation of the immune system. Patients will be randomized to receive either IM862 or placebo and will self-administer treatments by placing a few drops of IM862 solution or placebo into the nose every other day. Patients will be seen every 4 weeks for evaluation of response and toxicity. Key patient eligibility criteria include HIV infection, biopsy-proven Kaposi sarcoma with 5 or more measurable lesions, stable on antiretroviral therapy for at least 8 weeks, and no symptomatic visceral disease. Study duration is 6 months. Patients on placebo who experience disease progression or have stable disease at the end of the study will be offered continued IM862 treatment. Patients who have responded to the first 6 months of treatment may continue on blinded treatment.
Prospective patients should call (800) 818-0980. Information on the study is also available at the AIDS Clinical Trials Information Service Web site, found at http://www.actis.org/
Virax Holdings Limited received ethics committee approval to start a clinical trial of a vaccine (VIR201) to treat people recently infected with HIV and will now begin patient recruitment. The trial, to be conducted in Melbourne and Sydney, Australia, will be a controlled, multicenter, double-blind, randomized, parallel group study in 36 patients to evaluate Virax's Co-X-Gene with fowlpox virus (FPV) technology. It is designed to evaluate the safety of the VIR201 vaccine and its ability to enhance killer T cells in early-stage HIV patients. The study will be conducted in association with the National Centre in HIV Epidemiology and Clinical Research.
VIR201 is a live viral vector vaccine that uses FPV to carry genes from the HIV virus and a human cytokine to cells in the body in order to trigger a directed immune response. Patients will receive a series of injections and be closely monitored over 12 months. If the trial shows the predicted immune response, Virax may seek an international biopharmaceutical partner to fund larger, later-stage studies to show its effectiveness.