Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant
研究概览
简要总结
The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV patients >18 years old who provide signed and dated informed consent;
- •Males and females;
- •SOT recipients (heart, liver or kidney);
- •On stable antiretroviral therapy (ART) for ≥6 months preceding the screening visit;
- •Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
- •Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing
排除标准
- •HIV patients who have stopped ART due to virological failure;
- •HIV patients who require treatment with DTG contraindicated medications;
- •History or presence of an allergy or intolerance to the study drug;
- •Active opportunistic infection;
- •Neoplasms requiring chemotherapy.
- •Pregnancy or breast feeding or planned pregnancy during the study period
- •Any other contraindication to study drugs.
研究组 & 干预措施
HIV-1-infected solid organ transplant patients 1
The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus.
treatment 48 weeks
干预措施: Lamivudine 300 MG (Drug)
HIV-1-infected solid organ transplant patients 1
The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus.
treatment 48 weeks
干预措施: Abacavir 600 MG (Drug)
HIV-1-infected solid organ transplant patients 1
The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus.
treatment 48 weeks
干预措施: Dolutegravir 50 mg (Drug)
HIV-1-infected solid organ transplant patients 2
The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus.
treatment 48 weeks
干预措施: Dolutegravir 50 mg (Drug)
HIV-1-infected solid organ transplant patients 2
The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus.
treatment 48 weeks
干预措施: Tenofovir Disoproxil 245Mg Tablet (Drug)
HIV-1-infected solid organ transplant patients 2
The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus.
treatment 48 weeks
干预措施: Emtricitabine 200 MG (Drug)
结局指标
主要结局
Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant
时间窗: 24-hours before the switch and 24-hours 2 weeks after switching
Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA)
Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant
时间窗: 24-hours before the switch and 24-hours 2 weeks after switching
Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA).
Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant
时间窗: 24-hours before the switch and 24-hours 2 weeks after switching
次要结局
- Viral Resistance(week 48)
- Changes in CD4+ Cell(week 48)
- Lipid Profile(week 48)
- Renal Function(week 48)
- Safety: Number AEs and SAEs(week 48)