NCT00002268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 Viruria
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, 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.
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).
- •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.
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 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.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult ParticipantsHIV InfectionsNCT04212091National Institute of Allergy and Infectious Diseases (NIAID)33
已完成
1 期
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult ParticipantsHIV InfectionsNCT03928821National Institute of Allergy and Infectious Diseases (NIAID)27
已完成
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV InfectionChronic Hepatitis C VirusNCT01740791Gilead Sciences103
已完成
1 期
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis CChronic Hepatitis CNCT00227435Merck Sharp & Dohme LLC
终止
1 期
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) InfectionRespiratory Syncytial Virus InfectionsVirus DiseasesNCT02593851Janssen Sciences Ireland UC45