ISRCTN89417804已完成不适用
A phase I/IIa, double-blind study to evaluate the safety and tolerability, antiretroviral activity, pharmacokinetics and pharmacodynamics of IDX12899 in antiretroviral treatment-naïve HIV-1-infected subjects
Idenix Pharmaceuticals (USA)0 个研究点目标入组 40 人开始时间: 2008年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or Female, 21 to 65 years of age
- •2. Female of non-childbearing potential
- •3. Plasma HIV-1 RNA value >=5000 copies/mL
- •4. CD4+ count >=200 cells/mm3
- •5. Subject is antiretroviral treatment-naïve
- •6. Subject agrees to start a standard HAART regimen on Day 8 of the study or Kaletra® monotherapy for 28 days within 24 hours after the last dose of study medication
- •7. Subject has provided written informed consent to participate in the study
排除标准
- •1. Pregnant or breastfeeding
- •2. Male of reproductive potential and unwilling to use double barrier method of contraception during and for at least 30 days after the last dose of the study drug
- •3. Co-infection with acute hepatitis A (HAV), chronic hepatitis B (HBV) or active hepatitis C (HCV)
- •4. Alcohol or illicit drug abuse, or history of alcohol abuse or illicit drug abuse within the preceding one year
- •5. Potential allergy to the study medication or the follow-up HAART or Kaletra® therapy
- •6. Received an immunomodulating agent or immunotherapeutic vaccine within 30 days before Day -1
- •7. Receiving co-medication that is a known substrate, inhibitor and/or inducer of CYP3A4
- •8. Enrollment in another clinical study of an investigational agent
- •9. Subject who has received any investigational drug within 90 days prior to Day -1
- •10. History of AIDS-defining illness
- •11. History of or currently active disease that may put the subject at risk because of participation in this study
- •12. Subject with an intestinal malabsorption
- •13. Subject with a pre-existing Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) drug resistance based on genotyping at Screening
- •14. Subject who has had a significant blood loss 30 days prior to Day -1
- •15. Subject has any of the following laboratory parameters at Screening: hemoglobin <8.5 g/dL, neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, serum creatinine > the Upper Limit of Normal (ULN), ASpartate aminoTransferase (AST) or ALanine aminoTransferase (ALT) >=2.5 x ULN, Total bilirubin >
研究者
相似试验
已完成
1 期
Assessing the safety, pharmacokinetics and pharmacodynamics of single and 14 days dosing with two vaginal microbicide formulations containing either Darunavir, or Dapivirine and Darunavir.Topic: Infectious diseases and microbiologySubtopic: Infection (all Subtopics)Disease: Infectious diseases and microbiologyInfections and InfestationsISRCTN23353517York Hospital NHS Trust24
已完成
不适用
A randomised double-blind phase 1 study to assess the pharmacokinetics of C2F5, C2G12 and C4E10 when administered together in a gel vehicle as a vaginal microbicideHIVInfections and InfestationsISRCTN64808733York Hospitals NHS Foundation Trust (UK)30
进行中（未招募）
不适用
A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults (=67 years) previously vaccinated in the FluAS25-014 clinical trial with the same candidate vaccine. Fluarix™ (known as a-Rix® in Belgium) will be used as reference. - FluAS25-018 EXT 001 Y3Immunization against influenza in male and female subjects aged 67 years and older.EUCTR2007-002881-36-BEGlaxoSmithKline Biologicals74
进行中（未招募）
不适用
A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults (=66 years) previously vaccinated in the FluAS25-004 clinical trial with the same candidate vaccine. Fluarix™ (known as a-Rix in Belgium) administered in young (19-42 years) and elderly (=66 years) adults will be used as reference. - FluAS25-008 EXT:003 Y2Immunization against influenza in male and female subjects aged 66 years and older.EUCTR2007-002880-29-BEGlaxoSmithKline Biologicals
进行中（未招募）
不适用
A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults previously vaccinated in FluAS25-003 clinical trial with the same candidate vaccine. Fluarix™ administered in young and elderly adults will be used as reference. - FluAS25-004Immunisation against influenza disease in an elderly population aged over 65 yearsEUCTR2006-003236-30-BEGlaxoSmithKline Biologicals