NCT03033836已完成4 期
Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women
Fundación Huésped1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of transgender women retained in care at week 48
研究概览
简要总结
Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).
The primary objective of this pilot study is to determine the retention in care of TGW treated with DTG-TDF-FTC or 3TC
Secondary objectives:
- To evaluate the efficacy of the antiretroviral regimen at week 48 ;
- To describe the safety and tolerability of this regimen;
- To evaluate adherence across 48 weeks;
- To determine the patient satisfaction with this regimen;
- To identify individual, social and contextual factors associated with adherence and retention.
详细描述
The primary objective of this pilot study is to determine the retention in care of TGW treated with DTG-TDF-FTC.
The primary objective will be assessed by the proportion of individuals that provide information on ART use and virological outcomes at the end of the study:
- Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up.
- Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up.
Secondary objectives:
- To evaluate the efficacy of the antiretroviral regimen at week 48 ;
- To describe the safety and tolerability of this regimen;
- To evaluate adherence across 48 weeks;
- To determine the patient satisfaction with this regimen;
- To identify individual, social and contextual factors associated with adherence and retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV-1 positive serology by at least two different serological tests (rapid test, ELISA, Western Blot) or a viral load higher than 3,000 copies/mL.
- •18 years and older.
- •Self-identified as TGW
- •Written informed consent provided.
排除标准
- •Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel
- •Alcohol or drug use that might affect adherence.
- •Concomitant use of lipid-lowering drugs, interferon, interleukin-2, cytotoxic chemotherapy, dofetilide (or pilsicainide) or immunosuppressors, antacids drugs containing Ca++ and or Mg++ at study entry.
- •Opportunistic infection (CDC "C" category) or other disease and/or clinical conditions that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia.
- •Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of the investigational product.
- •Contraindication to any of the study drugs (history of renal diseases, lab abnormalities grade 4 or any other clinical condition prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements).
- •Anticipated need for Hepatitis C virus (HCV) therapy during the study.
- •Creatinine clearance of <50 mL/min via Cockroft-Gault method.
- •Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.
研究组 & 干预措施
single arm
Experimental
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
干预措施: ARV treatment (Drug)
结局指标
主要结局
Proportion of transgender women retained in care at week 48
时间窗: 48 weeks
Proportion of enrolled and dosed individuals that complete protocol defined visits during 48 weeks of follow up. Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up. Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up.
次要结局
- Proportion of individuals with HIV RNA undetectable at week 48(48 weeks)
- Adherence using ACTG form(From baseline to week 48)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events(From baseline to week 48)
- Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality(From baseline to week 48)
- Adherence using analogue visual scale(From week 4 to week 48)
- Patient´s satisfaction with this regimen(From baseline to week 48)
- Adherence by pill count(From week 4 to week 48)
- Quality of life by QoL Socre and Well being index(From baseline to week 48)
研究者
Omar Sued
PhD
Fundación Huésped
研究点 (1)
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