NCT00016588已完成不适用
An Open-Label Study to Assess the Anti-HIV-1 Activity of Tenofovir Disoproxil Fumarate (TDF) in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate (TDF) in HIV-infected patients who have never taken anti-HIV drugs.
详细描述
Patients receive TDF.
研究设计
- 研究类型
- Interventional
- 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
- •Patients may be eligible for this study if they:
- •Are HIV-positive.
- •Have a plasma viral load (level of HIV in the blood) of 10,000 copies/ml or more.
- •Have a CD4 count of 50 cells/mm3 or more.
- •Have a negative pregnancy test.
- •Agree to use 2 forms of barrier birth control while on the study and for 30 days afterwards.
- •Are 18 to 65 years old.
排除标准
- •Patients will not be eligible for this study if they:
- •Have had treatment with any of the following types of anti-HIV drugs: nucleoside reverse transcriptase inhibitors, nucleotide reverse transcriptase inhibitors (e.g., adefovir dipivoxil or TDF), protease inhibitors, or nonnucleoside reverse transcriptase inhibitors.
- •Have received a vaccination within 30 days before study entry.
- •Have had a new AIDS-defining illness diagnosed within 30 days before study entry.
- •Are taking any of the following: drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, cisplatin, foscarnet, intravenous (IV) amphotericin B, IV vancomycin, oral and IV ganciclovir, and valganciclovir; probenecid; chemotherapy; steroid drugs; interleukin-2; or investigational drugs.
- •Are pregnant or breast-feeding.
- •Have difficulty taking, absorbing, or tolerating drugs by mouth, as may be shown by long-term nausea or vomiting.
- •Abuse alcohol or drugs.
- •Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
- •Have other infections that need injectable antibiotics within 15 days before study entry.
- •Have had kidney or bone disease.
- •Have any medical conditions or past treatments that the study investigator believes would make the patient unsuitable for the study.
研究者
研究点 (1)
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