NCT00002016已完成1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 试验地点
- 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •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:
- •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.
排除标准
- •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:
- •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.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System DiseaseCytomegalovirus InfectionsNCT00004642National Center for Research Resources (NCRR)
终止
1 期
A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant RecipientsCytomegalovirus InfectionsSolid Organ TransplantNCT03950414University of Wisconsin, Madison2
已完成
2 期
V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)Cytomegalovirus (CMV) InfectionsNCT03486834Merck Sharp & Dohme LLC2,200
招募中
1 期
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell TransplantCytomegaloviral InfectionHematopoietic Cell Transplant RecipientNCT03354728City of Hope Medical Center80
已完成
1 期
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 ViruriaCytomegalovirus InfectionsHIV InfectionsNCT00002268Sandoz