NCT00002206已完成1 期
A Phase I/II, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 60 Mg Daily Dose of Adefovir Dipivoxil in HIV-Infected Patients Naive to Anti-Retroviral Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 8
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil.
详细描述
This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV infection, as indicated by a history of seropositivity for HIV-1 infection (ELISA confirmed with Western blot).
- •Peripheral blood CD4 cell count greater than or equal to 150 cells/mm3 on at least 1 measurement within 28 days prior to enrollment.
- •Plasma HIV-1 RNA greater than or equal to 5,000 copies/ml within 28 days of study entry.
- •A minimum life expectancy of 12 months.
排除标准
- •Co-existing Condition:
- •Patients with any of the following symptoms or conditions are excluded:
- •Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Patients should be considered recovered from such infectious episodes when at least 2 weeks have elapsed following the cessation of parenteral antibiotic therapy.
- •Evidence of a gastrointestinal malabsorption syndrome or inability to receive an orally-administered medication.
- •A malignancy other than cutaneous Kaposi's sarcoma (KS). (NOTE:
- •Patients with biopsy-confirmed KS are eligible, but must not have received any systemic therapy (including chemotherapy) for KS within 4 weeks prior to study entry.
- •1. Antiretroviral therapy, including nucleoside analogues, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational antiretroviral agents (antiretroviral therapy may be started after completion of the Day 35 follow-up visit).
- •Interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2).
- •Aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, chemotherapeutic agents (systemic), systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and other investigational agents.
- •1. Treatment with any HIV protease inhibitor.
- •Treatment for more than a total of 2 weeks with any nucleoside or nonnucleoside reverse transcriptase inhibitor antiretroviral agent.
- •Ongoing treatment with interferon (alpha, beta, or gamma), interleukins or other immunomodulatory agents, systemic corticosteroids, or any investigational agents except on sponsor's approval within 1 month prior to study entry.
- •Evidence of active substance abuse (including alcohol), as determined by the investigator, that would preclude adequate compliance with the protocol.
研究者
研究点 (8)
Loading locations...
相似试验
已完成
3 期
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis BChronic Hepatitis BNCT00857675GlaxoSmithKline480
已完成
2 期
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor TreatmentHIV InfectionsNCT00002419Gilead Sciences25
已完成
3 期
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis BChronic Hepatitis BNCT00095121Gilead Sciences173
撤回
2 期
Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)Hepatitis CHepatitis BHIV InfectionsNCT00051077National Institute of Allergy and Infectious Diseases (NIAID)
Unknown
2 期
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected ChildrenHIV InfectionsNCT00002219Gilead Sciences36