NCT00004981Unknown3 期
A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection
Glaxo Wellcome48 个研究点 分布在 1 个国家目标入组 230 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
- 发起方
- 入组人数
- 230
- 试验地点
- 48
研究概览
简要总结
The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
详细描述
Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients may be eligible for this study if they:
- •Are at least 18 years old.
- •Are HIV-positive.
- •Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
- •Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
- •Have CD4+ cell count greater than 200 cells/mm
- •Agree to use effective methods of birth control.
排除标准
- •Patients will not be eligible for this study if they:
- •Have been diagnosed with AIDS.
- •Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
- •Have hepatitis.
- •Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
- •Are allergic to any of the study drugs.
- •Abuse alcohol or drugs.
- •Will not be available for the entire 24-week study period.
- •Are pregnant or breast-feeding.
- •Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
- •Are enrolled in another experimental drug study.
研究者
研究点 (48)
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