NCT00011089Unknown不适用
US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options
适应症
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing.
详细描述
Patients receive daily doses of tenofovir DF.
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 HIV-positive.
- •Have a viral load (level of HIV in the blood) of at least 10,000 copies/ml by PCR within the previous 2 months.
- •Have a CD4 count of 100 cells/mm3 or lower within the previous 2 months. Patients with a CD4 count above 100 and as high as 200 cells/mm3 may also be eligible if they had an opportunistic (AIDS-related) infection within the past 90 days.
- •Have failed treatment with at least 2 protease inhibitors (PIs) or at least 1 PI plus a nonnucleoside reverse transcriptase inhibitor (NNRTI).
- •Are not able to get effective treatment with a combination of currently approved anti-HIV drugs.
- •Are at least 18 years old.
- •Have a negative serum pregnancy test.
- •Are willing to use a barrier method of birth control (both males and females) while on the study and for 30 days after taking the drug.
排除标准
- •Patients will not be eligible for this study if they:
- •Have or have had kidney disease or bone disease.
- •Are pregnant or breast-feeding.
- •Abuse alcohol or drugs.
- •Are taking, or have taken within 7 days of enrolling in the study, adefovir dipivoxil or drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, foscarnet, intravenous (IV) amphotericin B, IV pentamidine, IV vancomycin, and chemotherapy (e.g., cisplatin).
- •Have any medical conditions or have had any medications that the study investigator believes will make him/her unsuitable for the study.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV InfectionHIV InfectionsNCT00002453Gilead Sciences300
已完成
不适用
Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV DrugsHIV InfectionsNCT00016588Gilead Sciences
已完成
2 期
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIVHIV InfectionsNCT00122486FHI 3601,200
Unknown
4 期
TDF Dose Adjustment VS. Switching to TAF in TDF-experienced CHB Patients With Renal ImpairmentTenofovirRenal InsufficiencyNCT04391608Mahidol University80
已完成
4 期
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis BChronic Hepatitis BNCT01277601Gilead Sciences751