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A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria Clinical research trials and A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria. A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria clinical trial. Subjects typically recieve the finest healthcare available for their A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria  A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when administered once every 2 weeks for a total of 12 doses to patients with either AIDS or eligible AIDS-related complex (ARC) and with culture proven evidence of CMV viremia and/or viruria. Sandoglobulin will be employed as a comparative control.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Zidovudine (AZT). - Acyclovir. - Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection. - Trimethoprim / sulfamethoxazole (TMP / SMX). - Pyrimethamine / sulfadoxine. - Inhaled pentamidine. - Amphotericin B. - Ketoconazole. - Flucytosine (5-FC). - Antituberculosis therapy. - Recombinant human erythropoietin. - Recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF). - Recombinant human interferon alfa 2 for AIDS-related Kaposi's sarcoma. Patients must have: - AIDS or be HIV positive with CD4 lymphocyte counts below 200 cells/mm3 and be receiving prophylaxis for Pneumocystis carinii pneumonia (PCP) (with or without prophylaxis for another opportunistic infection), but have no prior medical history of an opportunistic infection. - Expected survival of = or > 6 months. - Willingness and ability to give written informed consent. - A copy of the signed and witnessed consent form must be maintained with the investigator's study files. - Positive culture results documenting the presence of cytomegalovirus (CMV) viremia and/or viruria. - Seropositive for the presence of circulating anti-CMV immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Significant pulmonary dysfunction. - Uncontrolled or unstable diabetes. - Significant cardiovascular disease including uncontrolled hypertension, congestive heart failure, cardiac arrhythmia, angina pectoris, or a history of myocardial infarction within one year of entry into the study. - Coagulation or hemorrhagic disorders. - Any active severe opportunistic infection. Concurrent Medication: Excluded: - Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol. - Any other experimental antiviral therapy. - Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol). Patients with the following are excluded: - Any significant organ system dysfunction as described in Exclusion co-existing conditions. - Previous history of or evidence of idiopathic thrombocytopenia purpura, agammaglobulinemia, or hypogammaglobulinemia. - Any other severe concomitant clinical condition. - Documented, active cytomegalovirus (CMV) disease (tissue or organ invasion/dysfunction) at baseline. To this end, baseline indirect funduscopy (to detect and exclude patients with peripheral CMV retinitis) will be performed. Prior Medication: Excluded within 2 weeks of study entry: - Therapy with ganciclovir (DHPG) or phosphonoformate (PFA) or other experimental anti-cytomegalovirus therapy except as stipulated in this protocol. - Any other experimental antiviral therapy. - Biologicals including immunoglobulin therapy (except those patients randomized to receive Sandoglobulin as specified in this protocol). - Excluded: - Prior treatment with monoclonal antibodies derived from any animal species. Prior Treatment: Excluded within 2 weeks of study entry: - Major surgery.
Total Enrollment:
Location and Contact Information:
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: 071A; Study No B102
Study Start Date:
Record last reviewed: December 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002268
Other Hiv Infections Studies:
1. Kinetics of response of cytomegalovirus with ganciclovir treatment using quantitative real-time PCR
2. Potential Role of CMV in Restenosis Following Angioplasty, in Atherosclerosis, and in Endothelial Dysfunction
3. Immune Response to Cytomegalovirus
4. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
5. Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
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A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
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