EUCTR2008-001486-28-BE进行中（未招募）不适用
A phase 3, open-label 96-week extension study of the safety of apricitabine in treatment-experienced HIV-1 infected patients who have completed protocol AVX-301 or AVX-302 or who have met the criteria for open-label access to ATC because ofvirologic failure/lack of response. - 303
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,866
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. (a) Patients who complete studies AVX-301 or AVX-302 and fulfill the following
- •- Plasma HIV-1 RNA levels =2,000 copies/mL
- •- Patients with plasma HIV-1 RNA levels >2,000 copies/mL should be discussed on an individual basis with the Sponsor.
- •(b) Patients who meet the criteria for open-label access to ATC because of virologic
- •failure/lack of response in study AVX-301 or AVX-302, and who are withdrawn from
- •those studies for that reason, and who fulfill the following criteria:
- •- Demonstration of presence of M184V/I mutation, and absence of Q151M or 69 insertions, in reverse transcriptase at Screening.
- •Note: Virologic failure is defined as the HIV-1 RNA level increasing by >1.0 log10
- •copies/mL (confirmed on two separate occasions at least one week apart) from the
- •nadir value recorded during the study.
- •2. Unrestricted CD4+ cell count.
- •3. 18 years of age, or older.
- •4. Male, or non-pregnant, non-breastfeeding female patients, who agree to comply
- •with the applicable contraceptive requirements of the protocol.
- •5. The patient must understand and be able, willing and likely to fully comply with
- •study procedures and restrictions.
- •6. 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. Patients enrolled in study AVX-304.
- •2. Considered unlikely to be ART compliant (OBR or investigational product) by the
- •Investigator.
- •3. Documented major protocol violation(s) during AVX-301 or AVX-302 including noncompliance with study medication and/or OBR.
- •4. Prior withdrawal from AVX-301 or AVX-302 for any reason. Patients who wish to
- •withdraw from AVX-301 or AVX-302 and enter AVX-303 on the grounds of protocol-defined virologic failure or lack of response must continue in AVX-301 or AVX-302 until screening for AVX-303 is complete and eligibility confirmed.
- •5. Patients who have previously been enrolled into this study and subsequently
- •6. Current acute or chronic hepatitis B virus infection (HBsAg positive and requiring
- •treatment in the next 12 months).
- •a. Previous, resolved HBV infection (HBsAg seronegative with seropositivity for IgG-anti-HBc and/or anti-HBs antibodies) is permitted.
- •b. Well controlled HBV-infected patients not taking tenofovir as part of the OBR
- •who have been receiving adefovir dipivoxil continuously since at least 30 days prior to screening in AVX-301, who meet the requirements for AST and ALT <3 x ULN and who continue to receive adefovir dipivoxil for the duration of the study may be enrolled.
- •7. Current treatment for hepatitis C virus infection or treatment likely within 12 months.
- •8. Current or relevant previous history of serious, severe or unstable (acute or
- •progressive) physical or psychiatric illness, any medical disorder that may require
- •treatment or make the patient unlikely to fully complete the study, or any condition
- •that presents undue risk from the investigational product or procedures, as determined by the investigator. Also, any current or recurring disease or intolerance to investigational product that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments, as determined by the Investigator.
- •9. Clinically relevant abnormalities of medical history, physical examination, or
- •laboratory parameters (hematology, biochemistry, urinalysis).
- •10. Patients with any of the following abnormal clinical laboratory tests at Screening:
- •a. hemoglobin <10.0g/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. The patient has, in the opinion of the Investigator, a dependence on alcohol or other substance abuse within 6 months of Screening.
- •12. Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial or antiparasitic therapy within 15 days prior to Screening.
- •13. Female patients with a positive pregnancy test at Screening or Baseline, or who are breastfeeding, or who plan to become pregnant during the duration of the study
- •and any follow up.
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