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A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis Clinical research trials and A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis. A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis  A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.
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) < 600 mg/day. - Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection. - Trimethoprim / sulfamethoxazole (TMP / SMX). - Pyrimethamine / sulfadoxine. - Aerosolized pentamidine. - Ketoconazole. - Flucytosine (5-FC). - Antituberculosis therapy. Concurrent Treatment: Allowed: - Maintenance phase of ganciclovir (DHPG) therapy. Patients must have: - AIDS with documented ophthalmologic findings consistent with cytomegalovirus (CMV) retinitis whose retinal lesions are less than 750 microns from the fovea and who have visual symptoms of CMV retinitis. - Completed the treatment induction phase with ganciclovir (DHPG) and be about to participate in the maintenance phase DHPG therapy. - 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. - 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 amphotericin B or fluconazole. - Any other investigational drug. - Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating-factor (GM-CSF), erythropoietin alpha, or any interleukin. Patients with the following are excluded: - Any significant organ system dysfunction as described in Exclusion Co-existing Conditions. - Any other severe concomitant clinical condition. Prior Medication: Excluded within 2 weeks of study entry: - Therapy with amphotericin B or fluconazole. - Any other investigational drug. - Biologicals including immunoglobulin therapy, granulocyte-macrophage-colony-stimulating factor (GM-CSF), erythropoietin alpha, or any interleukin. - 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
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: 071B; Study No B103
Study Start Date:
Record last reviewed: April 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002016
Other Hiv Infections Studies:
1. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
2. A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
3. Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis
4. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
5. The Safety and Effectiveness of Ganciclovir Used Alone or in Combination with Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients with AIDS
Related Studies:
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Other Galveston Clinical Trials
A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
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