NCT00084253已完成4 期
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).
研究概览
简要总结
The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •HIV RNA greater than or equal 200 copies/mL at screening
- •18 years old or older
- •Must use barrier contraception
- •Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications
排除标准
- •Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study
- •Women using oral contraceptives, pregnant or breastfeeding women
- •Women who have a positive pregnancy test on enrollment or before beginning to take the study medications
- •People who have a life expectancy of greater than 12 months
- •Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
- •Any antiretroviral therapy within 30 days prior to screening
- •Any prior antiretroviral therapy (greater than 30 days of NRTI and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (NNRTI) or protease inhibitor therapies)
- •Any of the following conditions: Cushings Syndrome, Gilbert's Syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) HIV infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, Intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease
- •Active alcohol or substance abuse
- •History or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening
- •Previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4
- •Inability to swallow capsules
研究组 & 干预措施
1
Active Comparator
干预措施: Atazanavir/ Stavidine / Lamivudine (Drug)
2
Active Comparator
干预措施: Atazanavir-Ritonavir/ Stavidine / Lamivudine (Drug)
结局指标
主要结局
To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).
次要结局
未报告次要终点
研究者
研究点 (1)
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