EUCTR2017-004160-35-DE进行中（未招募）1 期
A prospective, randomised, controlled, parallel arm, open phase IIa study on the efficacy and safety of the GnRH analogue triptorelin for HIV-1 reservoir reduction in HIV-1 infected male adult patients on suppressive ART
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- Male
入选标准
- •1.Male gender
- •2.18 to 65 years of age, inclusive, at the time of informed consent
- •3.Ability and willingness to give a written informed consent. A signed informed consent must be available prior to any study-related procedures.
- •4.HIV-1 infection as documented by HIV antibody test
- •5.CD4+ cell count >300 cells/µL at screening
- •6.Total HIV-1 DNA level between 100 to 5000 copies/million PBMC as measured by real-time PCR within 4 months prior to screening
- •7.Plasma HIV-1 RNA level <50 copies/mL for the last year (one blip allowed; blip defined as HIV RNA between 50-150 copies/mL) including a plasma HIV-1 RNA level <50 copies/mL at screening
- •8.On triple combination ART (two nucleoside reverse transcriptase inhibitors (NRTI) + one integrase inhibitor or protease inhibitor or one non-NRTI (NNRTI)) for minimum 36 months (assessed at screening)
- •9.Currently on continuous triple combination ART as specified above (i.e. no changes in medication) the past 4 months prior to screening
- •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 52
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Treatment failure while on triple ART
- •2.Nadir CD4+ count < 200 cells/µL
- •3.History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
- •4.For Germany: Positive antibody test for hepatitis B at screening. Positive antibody test for hepatitis C (HCV) at screening unless the patient has been treated for HCV and assessed as cured by the treating physician (including an HCV RNA negative test)
- •5.Serious ongoing infection, including SARS-CoV-2 infection (checked by body temperature control and interview form).
- •6.Abnormal liver biochemical tests > 2 x upper limit of normal (ULN) of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP)
- •7.Total testosterone, LH or FSH levels at screening assessed as clinically abnormal by the Investigator
- •8.Current treatment with testosterone
- •9.History of any clinically significant kidney disease as determined by the Investigator or eGFR < 60 mL/min/1.73 m2 at screening. (Patients on dolutegravir with an eGFR<60 may be verified for study inclusion by analysis of cystatin C that should then be assessed as normal by the Investigator in order for the patient to be eligible)
- •10.Diabetes mellitus or a fasting plasma blood glucose >7.0 mmol/L at screening
- •11.Intolerance or contraindication to injectable triptorelin
- •12.Vital signs, physical examination or lab results that exhibit evidence of acute illness
- •13.Known history of moderate or severe depression (see definitions in ICD-10) within the past 5 years
- •14.Any congenital or acquired prolongation of the QTc interval and use of any drugs that has been proven to prolong the QTc interval (Normal QTc interval defined as <450 msec)
- •15.An increased PSA (Prostate Specific Antigen) value that is assessed as abnormal by the treating physician
- •16.Involvement in any other drug study within 30 days prior to this study entry
- •17.Any medical condition that in the opinion of the Investigator would compromise the patient’s ability to participate in the study
- •18.Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
- •19. Condition or concomitant anti-coagulation treatment making intramuscular injections contraindicated (note that treatment with acetylsalicylic acid is permitted).
- •20. For Germany: Person concerned has been admitted to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •21. For Germany: CRO or Sponsor employees or employees under the direct supervision of the Investigator or the investigational sites and/or involved directly in the study.
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