An Interventional, One-arm, Open Label Pilot Study to Assess the Feasibility of Dolutegravir Monotherapy in Virologically Suppressed Patients on Conventional Triple Antiretroviral Therapy of Dolutegravir Plus Two Nucleoside Reverse Transcriptase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before
研究概览
简要总结
Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.
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
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection;
- •Patient included in the Swiss HIV Cohort Study (SHCS);
- •≥ 18 years of age;
- •Virologically suppressed for at least 24 months on first line triple ART (changes for toxicity permitted) with at least 4 HIV-1 RNA measurements in plasma <50 copies/ml;
- •No history of previous failure on ART;
- •No documented antiretroviral drugs resistance;
- •No co-infection with Hepatitis B or C virus;
- •Effective contraception in women;
- •Willing to provide CSF and semen samples;
- •Written informed consent
排除标准
- •HIV-2 infection;
- •Renal dysfunction (creatinine clearance <50ml/min);
- •aspartate transaminase or alanine aminotransferase >5x upper limit normal;
- •Concomitant use of carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, rifampicin or metformin;
- •Previous AIDS defining conditions or active malignancy in the past five years;
- •Positive HIV viral load in CSF at baseline;
- •Known or suspected non-compliance;
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
Dolutegravir monotherapy
10 patients will be simplified to monotherapy of dolutegravir tablet 50mg once daily for 24 weeks
干预措施: Dolutegravir (Drug)
结局指标
主要结局
Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before
时间窗: week 24
次要结局
- Quantification of the HIV-1 DNA reservoir in peripheral blood monocyte cells at baseline and week 24(week 24)
- Emergence of genotypic resistance in plasma HIV-1 RNA in case of virological failure(week 24)
- Body fat composition as measured by dual energy x-ray absorptiometry (DXA) scan at baseline and week 24(week 24)
- Quantification HIV-1 RNA levels in the CSF and semen at baseline and week 24(week 24)
- Change from baseline CD4 cell count from baseline at week 24(week 24)
- Change in bone mineral density from baseline to week 24(week 24)
- Adherence to medication at weeks 4, 8, 12, 16, 20, 24(week 24)
- Lipidic profile changes from baseline at week 24(week 24)
研究者
Calmy Alexandra
Médecin adjointe agrégée, HIV Unit director, Infectious Diseases Division
University Hospital, Geneva