NCT00002033已完成不适用
A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
Wyeth is now a wholly owned subsidiary of Pfizer8 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 8
研究概览
简要总结
To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic function in HIV positive patients with advanced disease. To compare the effect of AS-101 to that of placebo on occurrence of disease progression in HIV positive patients with advanced disease as defined by: (1) development of new diagnostically confirmed major opportunistic infection(s); or (2) development of AIDS-related dementia. To compare the effect of zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and immunologic function in patients who require anti-viral therapy due to disease progression. Garlic capsules will be given to all study participants to mask the obvious garlic odor of AS-101.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Standard therapy including acyclovir or ganciclovir for infections that develop during the study period. (Prophylactic acyclovir is not permitted.) Standard therapy for persistent infections may continue.
- •Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor.
- •Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks.
- •Garlic capsules will be given to all study participants to mask side effects of AS-
- •Required:
- •Accepted standard prophylaxis for patients with prior Pneumocystis carinii pneumonia (PCP).
- •Patients must have the following:
- •Diagnosis of AIDS or AIDS-related complex (ARC).
- •Life expectancy > 6 months.
- •Provide written informed consent.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Evidence of severe liver dysfunction (serum albumin < 2.5 g/dl, prothrombin time > 15 seconds or SGOT or SGPT > 3 x upper limits of normal), gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorders which would prevent compliance with the protocol.
- •Evidence of AIDS related dementia.
- •Presence of disseminated Kaposi's sarcoma defined as any visceral lesions or > 20 cutaneous lesions; or Kaposi's sarcoma without at least one other AIDS defining characteristic.
- •Presence of any lymphoma.
- •Active opportunistic infection currently requiring treatment unless the infection has stabilized and continuing treatment is only required to prevent relapse (e.g., CNS toxoplasmosis or resolving tuberculosis).
- •Concurrent Medication:
- •Prophylactic acyclovir.
- •Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor.
- •Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks.
- •Patients with the following are excluded:
- •Evidence of severe organ dysfunction as defined in Exclusion complications or other specified disease conditions.
- •Unlikely or unable to comply with the requirements of the protocol.
- •Prior Medication:
- •Excluded within 8 weeks of study entry:
- •Any immune stimulation agents such as BCG vaccine, interferons, or other immune modulators within 8 weeks.
- •Any immunosuppressive agent within 8 weeks.
- •Excluded within 12 weeks of study entry:
- •Zidovudine (AZT).
研究者
研究点 (8)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)Cytomegalovirus (CMV)-Positive RecipientsAllogeneic, Hematopoietic Cell Transplant (HCT)NCT01877655Astellas Pharma Global Development, Inc.514
已完成
3 期
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneeKnee OsteoarthritisNCT06000410Organogenesis594
已完成
3 期
Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneeKnee OsteoarthritisNCT04636229Organogenesis516
已完成
3 期
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.Meningococcal DiseaseInfections, MeningococcalNCT01682876GlaxoSmithKline715
已完成
1 期
Drug to Drug Interaction Study With ASP1941 and MetforminType 2 Diabetes MellitusNCT01302145Astellas Pharma Inc36