EUCTR2007-003281-18-IT进行中（未招募）不适用
A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,014
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •HIV-1 positive with M184V/I mutation in reverse transcriptase 18 years of age or older Stable ART regimen containing either lamivudine (3TC) or emtricitabine (FTC) unchanged for at least 2 months prior to baseline At least 2-class experienced Plasma HIV-1 RNA 2,000 copies/mL Unrestricted CD4+ cell count Written, informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •HIV-2 infection Presence of Q151M or 69 insertion mutations in HIV-1 reverse transcriptase Clinically relevant current or recurring disease, illness or laboratory abnormality likely to require treatment during the study that could affect interpretation of efficacy end-points eg, HIV-1 RNA levels Female patients with a positive pregnancy test or who are breastfeeding Current active hepatitis B virus (HBV) infection, (HBsAg positive and requiring treatment within the next 12 months) o Well controlled HBV-infected patients not taking tenofovir as part of the OBR and who have been receiving adefovir dipivoxil for at least 30d prior to screening, who meet the requirements for AST and ALT < 3 times upper limit of normal range (ULN) and who continue on adefovir dipivoxil for the duration of the study may be enrolled. Adefovir dipivoxil should not be prescribed concurrently with tenofovir in this study due to concerns over potential renal toxicity. Current treatment for hepatitis C virus infection, or treatment required within the next 12 months A new AIDS-defining condition (Category C, Appendix 1) diagnosed within 42 days prior to baseline with the exception of CD4 cells <200/mm3, Kaposi?s sarcoma (KS) confined to the skin and HIV-wasting disease ie, wasting not related to any other known cause Patients who, within 42 days prior to baseline, have received immunomodulating agents, immunization other than for influenza or pneumococcus, systemic chemotherapeutic agents, an HIV prophylactic or immunotherapeutic vaccine Haemoglobin <10.0 g/dL for men and <9.0 g/dL for women Neutrophil count <750/mm3 Platelet count <50,000/mm3 AST or ALT ≥3 times ULN Total bilirubin is >1.5 x ULN, with the exception of patients receiving atazanavir or any other medication known to elevate the indirect bilirubin level as long as the direct bilirubin is less than the ULN. Lipase >3 times ULN Amylase >3 times ULN (unless serum lipase is 1.5 times the ULN) Estimated creatinine clearance (Cockcroft Gault) <50mL/min Patients who have previously received ATC.
研究者
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