EUCTR2007-003281-18-FR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 - AVX-301
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
- •To be eligible for inclusion, each patient must fulfil each of the following criteria at Screening:
- •1. 18 years of age, or older.
- •2. Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol
- •3. Documented laboratory diagnosis of HIV-1 infection (positive ELISA HIV-1 antibody test confirmed by Western Blot, p24 assay, HIV-1 RNA, or culture); if no record exists, must be tested at screening.
- •4. Currently receiving stable ART regimen comprising at least three drugs, and containing either lamivudine or emtricitabine that is unchanged for at least 2 months prior to first dose of Investigational Product.
- •5. Plasma HIV-1 RNA levels =2,000 copies/mL at Screening using the Roche Cobas Ampliprep / Cobas Taqman (dynamic range 40-10,000,000 copies per mL) performed at the central laboratory.
- •6. Presence of the M184V/I mutation in reverse transcriptase at Screening.
- •7. Unrestricted CD4+ cell count.
- •8. The patient must understand and be able, willing and likely to fully comply with study procedures and restrictions.
- •9. Written/marked, informed consent to participate in the study prior to the conduct of any study related procedures.
- •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
- •Patients will be excluded from the study if any of the following criteria are met at Screening:
- •1. Previous documented laboratory diagnosis of HIV-2 infection
- •2. Presence of Q151M or 69 insertion mutations in reverse transcriptase.
- •3. Considered to be significantly and chronically ART non-compliant by the Investigator.
- •4. Current or recurring disease that could affect the action, absorption or disposition of the Investigational Product, or clinical or laboratory assessments, as determined by the investigator.
- •5. Current acute or chronic Hepatitis B virus infection (HBsAg positive and requiring treatment in the next 12 months).
- •- Previous, resolved HBV infection is permitted.
- •- 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.
- •6. Current treatment for Hepatitis C virus infection or treatment likely during the duration of the study..
- •7. 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), prevent the patient from fully complying with the study, or present undue risk from the Investigational Product or procedures, as determined by the Investigator.
- •8. A new AIDS-defining condition (defined in Category C, Appendix 1) diagnosed within 42 days prior to the first dose of Investigational Product with the exception of
- •a. CD4 cells <200/mm3
- •b. Kaposi’s sarcoma (KS) confined to the skin
- •c. HIV-wasting disease ie, wasting not related to any other known cause
- •9. Patients who, within 42 days prior to the first dose of Investigational Product, have received any of the following:
- •a. immunomodulating agents such as systemic corticosteroids (eg, prednisone or prednisolone exceeding 10mg/day or equivalent dose of any other corticosteroid for more than 7 days), interleukin (IL)-2, IFN-?, IFN-? or IFN-?
- •b. immunization other than for influenza and pneumococcus
- •c. systemic chemotherapeutic agents
- •d. an HIV prophylactic or immunotherapeutic vaccine
- •10. Patients with any of the following abnormal clinical laboratory tests at Screening:
- •a. Hemoglobin <10.0 g/dL for men and <9.0g/dL for women
- •b. Neutrophil count < 750/mm3
- •c. Platelet count <50,000/mm3
- •d. AST or ALT =3 times the upper limit of normal (ULN)
- •e. 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.
- •f. Lipase >3 times ULN
- •g. Amylase >3 times ULN (unless serum lipase is ? 1.5 times ULN)
- •h. Estimated Creatinine Clearance <50mL/min (estimated by Cockcroft and Gault equation)
- •11. Known or suspected intolerance or hypersensitivity to ATC, lamivudine or any of the stated ingredients
- •12. The patient has, in the opinion of the Investigator, a dependence on alcohol or other substance abuse within 6 months of Screening that will likely interfere with study compliance and/or make difficult the objective interpretation of clinical and/or laboratory data.
- •13. Active, serious infections (other
研究者
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