NCT00000653已完成2 期
A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
National Institute of Allergy and Infectious Diseases (NIAID)35 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 35
研究概览
简要总结
To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.
As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
详细描述
As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
Patients receive oral ddC for 48 to 177 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Amphotericin B (1 mg/kg up to 5 days/week).
- •Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia.
- •Acyclovir (up to 1000 mg/day PO; for > 1000 mg/day PO or for any IV dose, suggest interrupting ddC).
- •Ketoconazole (up to 10 mg/kg/day).
- •Nystatin.
- •Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours).
- •Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25
- •50 mg/day to avoid possible INH-associated neuropathy.
- •Trimethoprim / sulfamethoxazole (T/S).
- •Immunoglobulin therapy.
- •Aerosolized pentamidine.
- •Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition.
- •Concurrent Treatment:
- •Immunoglobulin therapy.
- •Nutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements.
- •Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study.
- •ORIGINAL design:
- •Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol.
- •Patients must have the following:
- •Absence of acute opportunistic infection at time of entry.
- •However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for > 4 weeks are eligible.
- •Parent or guardian available to give written informed consent.
- •Allowed at time of study entry:
- •Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP).
- •Immunoglobulin therapy.
- •Prior Medication:
- •AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry
- •Zidovudine (AZT) within 4 weeks of entry.
- •Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI.
- •Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC.
- •Vitamin, folate, iron supplements.
排除标准
- •Co-existing Condition:
- •04-25-91 Additional excluded symptoms and conditions:
- •Symptomatic cardiomyopathy.
- •Seizures which are not well controlled by ongoing anticonvulsant therapy.
- •Active malignancy requiring concomitant chemotherapy.
- •Symptomatic pancreatitis.
- •Grade I or greater peripheral neuropathy.
- •Receiving concomitant zidovudine (AZT).
- •Patients with the following conditions or symptoms are excluded:
- •Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
- •Known hypersensitivity to dideoxycytidine (ddC).
- •Concurrent Medication:
- •Other antiviral agents, biological modifiers, and investigational medications.
- •Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin.
- •Patients with the following are excluded:
- •Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
- •Known hypersensitivity to dideoxycytidine (ddC).
- •Active opportunistic infection requiring treatment with an excluded concomitant medication.
- •Prior Medication:
- •Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry.
- •Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
- •Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
研究者
研究点 (35)
Loading locations...
相似试验
已完成
不适用
A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV DiseaseHIV InfectionsNCT00000719National Institute of Allergy and Infectious Diseases (NIAID)96
已完成
2 期
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take ZidovudineHIV InfectionsNCT00000963National Institute of Allergy and Infectious Diseases (NIAID)300
已完成
1 期
A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.HIV InfectionsNCT00000704National Institute of Allergy and Infectious Diseases (NIAID)64
已完成
4 期
Doxycycline Prophylaxis at Vacuum Aspiration TrialEndometritisNCT00547170University of Pittsburgh1,000
已完成
1 期
The Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930HealthyNCT03034486Chong Kun Dang Pharmaceutical15