NCT03536234Unknown2 期
A Prospective, Randomized, Open Study on the Efficacy and Safety of the GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients
Immune System Regulation AB5 个研究点 分布在 2 个国家目标入组 52 人开始时间: 2018年9月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Mean change from baseline to week 12 in total HIV-1 DNA levels in CD4+ cells in the active group compared to the mean change in the control group.
研究概览
简要总结
An open, randomised, parallel arm phase IIa study. 52 HIV-1 infected patients will be randomised (in a 1:1 ratio) to either an active group or a control group. The active group will receive the GnRH analogue triptorelin depot monthly at baseline, week 4 and week 8. Patients in the active group and in the control group will continue their triple combination antiretroviral therapy (ART) during the study without changes; unless there is rationale for change on medical ground. In order to prevent the negative effects of a low testosterone level, patients in the active group will be offered to receive a single intramuscular depot injection of testosterone approximately 7 days after triptorelin treatment. This depot administration will keep the serum testosterone on a normal level until the next triptorelin dose. This will be repeated when triptorelin is administered at week 4 and week 8. Total study period is 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male gender
- •18 to 65 years of age, inclusive, at the time of informed consent
- •Ability and willingness to give a written or orally witnessed informed consent
- •HIV-1 infection as documented by HIV antibody test
- •CD4+ cell count >300 cells/μL at screening
- •Total HIV-1 DNA level between 100 to 5000 copies/million PBMC as measured by real-time PCR within 4 months prior to screening
- •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
- •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)
- •Currently on continuous triple combination ART as specified above (i.e. no changes in medication) the past 4 months prior to screening
排除标准
- •Treatment failure while on triple ART
- •Nadir CD4+ count < 200 cells/μL
- •History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
- •Known positive result of screening for hepatitis B (surface antigen positive or detectable HBV DNA levels in blood) or hepatitis C (HCV RNA positive). Patient treated for HCV and assessed as cured by treating physician is eligible for the study
- •Serious ongoing infection
- •Abnormal liver biochemical tests > 2 x upper limit of normal (ULN) of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP)
- •Total testosterone, LH or FSH levels at screening assessed as clinically abnormal by the Investigator
- •Current treatment with testosterone
- •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)
- •Diabetes mellitus or a fasting plasma blood glucose >7.0 mmol/L at screening
- •Intolerance or contraindication to injectable triptorelin
- •Vital signs, physical examination or lab results that exhibit evidence of acute illness
- •Known history of moderate or severe depression (see definitions in ICD-10) within the past 5 years
- •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)
- •Involvement in any other drug study within 30 days prior to this study entry
- •An increased PSA (Prostate Specific Antigen) value that is assessed as abnormal by the treating physician
- •Any medical condition that in the opinion of the Investigator would compromise the patient's ability to participate in the study
- •Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
研究组 & 干预措施
Triptorelin (GnRH analogue)
Experimental
干预措施: Triptorelin acetate depot (Drug)
结局指标
主要结局
Mean change from baseline to week 12 in total HIV-1 DNA levels in CD4+ cells in the active group compared to the mean change in the control group.
时间窗: Baseline to 12 weeks time point
次要结局
- Number of adverse events in active group compared to control group(Baseline to 12 weeks time point)
- Mean change in the CD8+ T-cell counts from baseline to week 12 in the active group compared to the mean change in the control group.(Baseline to 12 weeks time point)
- Mean change of the HLA class 1 expression from baseline to week 12 in the active group compared to the mean change in the control group(Baseline to 12 weeks time point)
- Mean change in the CD4+ T-cell counts from baseline to week 12 in the active group compared to the mean change in the control group.(Baseline to 12 weeks time point)
- Number and percentage of patients reporting any adverse events in active group compared to control group(Baseline to 12 weeks time point)
研究者
研究点 (5)
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