NCT00002354已完成不适用
One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.
- •Patients must have:
- •HIV infection.
- •CD4 count 50 - 500 cells/mm
- •Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
- •No active opportunistic infection or visceral Kaposi's sarcoma.
- •Patients with hemophilia may be enrolled at discretion of investigator.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Symptomatic neuropathy.
- •Acute hepatitis.
- •Concurrent Medication:
- •Antiretrovirals other than specified in protocol.
- •Chronic therapy for an active opportunistic infection.
- •Immunosuppressive therapy.
- •Prior Medication:
- •Any prior protease inhibitor or d4T.
- •Any nucleoside analogs within 2 weeks prior to study entry.
- •Investigational agents or immunomodulators within 30 days prior to study entry.
- •More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their InfantsPregnancyHIV InfectionsNCT00000944National Institute of Allergy and Infectious Diseases (NIAID)24
已完成
1 期
Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected PatientsHIV InfectionsNCT00002403Aronex Pharmaceuticals12
Unknown
2 期
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice DailyHIV InfectionsNCT00002241Merck Sharp & Dohme LLC80
已完成
1 期
A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and ChildrenHIV InfectionsNCT00000952National Institute of Allergy and Infectious Diseases (NIAID)60
已完成
1 期
Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected InfantsHIV InfectionsNCT00038480National Institute of Allergy and Infectious Diseases (NIAID)31