NCT00004581已完成3 期
A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
Abbott88 个研究点 分布在 11 个国家目标入组 300 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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 88
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).
详细描述
Patients receive 1 of the following:
- ABT-378/RTV plus NVP plus 2 NRTIs; or
- Investigator-selected PI(s) plus NVP plus 2 NRTIs.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be eligible for this study if they:
- •Are at least 12 years old.
- •Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
- •Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
- •Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
- •Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.
排除标准
- •Patients will not be eligible for this study if they:
- •Have an active illness.
- •Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
- •Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- •Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
- •Have received treatment with a PI other than their current PI.
- •Are receiving chemotherapy for cancer.
- •Are pregnant or breast-feeding.
研究者
研究点 (88)
Loading locations...
相似试验
已完成
3 期
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected PatientsHIV InfectionsNCT00002410Dupont Merck
终止
不适用
Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing NelfinavirHIV InfectionsNCT00006326Agouron Pharmaceuticals60
已完成
2 期
A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment FailureHIV InfectionsNCT00000918National Institute of Allergy and Infectious Diseases (NIAID)300
已完成
3 期
Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV InfectionHIV InfectionsNCT00013520National Institute of Allergy and Infectious Diseases (NIAID)1,125
已完成
3 期
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in BangladeshVisceral LeishmaniasisNCT01122771Drugs for Neglected Diseases602