NCT00038220已完成2 期
A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.
研究概览
简要总结
The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have HIV Infection.
- •Age 18 to 65 years old.
- •Show no signs of recent illness other than HIV infection.
- •Agree to use a barrier method of birth control during the study and for 30 days after study.
排除标准
- •Are unable to follow study requirements (in the opinion of the investigator).
- •Are pregnant or breast-feeding.
- •Are unable to take medications by mouth.
- •Have chronic nausea or vomiting.
- •Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
- •Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening.
- •Are taking any medications that are not allowed with ABT-378/r and efavirenz.
- •Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor.
- •Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor.
- •Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements.
- •Have a history of kidney or bone disease.
结局指标
主要结局
Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.
次要结局
未报告次要终点
研究者
研究点 (1)
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