2023-509751-14-03招募中2 期
Efficacy of doravirine + dolutegravir dual therapy in the context of antiretroviral therapy switch
Chelsea And Westminster Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint will be a comparison of the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48. Undetectable will be defined as plasma RNA levels of <50 copies/ml. Any patient with HIV RNA levels >50 copies/ml at analysis time points will have a repeat test. If the result from the repeat test is below 50 copies/ml the participant will be classified as a responder.
研究概览
简要总结
To evaluate the efficacy of switching from suppressive triple cART to doravirine and dolutegravir dual cART in PLWH on ART with an undetectable viral load.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected, 18 years or older
- •On stable & suppressive triple cART for at least 6 months (this can include DOR and/or DTG)
- •No evidence of resistance to DOR or DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG)
- •No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
- •Women who are of childbearing potential (WOCBP) and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation:
- •Progesterone injection
- •Intra-uterine device or system
- •Oral hormonal contraception
- •Men who are sexually active and have partners who are women of childbearing potential must be using an adequate method of contraception to avoid pregnancy (male condom or sterilisation confirmed prior to the subject’s entry into the study)
排除标准
- •History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
- •Known acute or chronic viral hepatitis B or C. Exceptions:
- •Individuals testing positive for HBcAb, but negative HBsAg/HBeAg, may be included on the trial.
- •Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.
- •Pregnant or breastfeeding women
- •Hypersensitivity to the active substance or to any of the excipients in the dolutegravir and/or doravirine formulations
- •Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- •History of virological failure on an INSTI in absence of a post-failure genotypic resistance test proving absence of resistance to DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG – and the subject will be considered NOT eligible)
- •Concomitant medication contra-indicated with DTG or DOR
- •Haemoglobin <9 g/dL
- •Platelets <80,000/mm3
- •Creatinine clearance <30 mL/min
- •AST or ALT ≥5N
- •Acute Hepatitis A infection
- •Concomitant DAA for anti-HCV therapy
结局指标
主要结局
The primary endpoint will be a comparison of the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48. Undetectable will be defined as plasma RNA levels of <50 copies/ml. Any patient with HIV RNA levels >50 copies/ml at analysis time points will have a repeat test. If the result from the repeat test is below 50 copies/ml the participant will be classified as a responder.
The primary endpoint will be a comparison of the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48. Undetectable will be defined as plasma RNA levels of <50 copies/ml. Any patient with HIV RNA levels >50 copies/ml at analysis time points will have a repeat test. If the result from the repeat test is below 50 copies/ml the participant will be classified as a responder.
次要结局
- Absolute efficacy of study treatments: Proportion of patients treated on each arm with HIV viral load <50 copies/ml at weeks 24,72,96.
- Safety and tolerability: 1 Occurrence of adverse events (including laboratory results), severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatments.
- Safety and tolerability- 2. Changes in CD4 count and CD4:CD8 ratio at screening, weeks 24, 48, 72 and 96
- Safety and tolerability - 3. Occurrences and details of viral resistance in study participants
- Safety and tolerability- 4. Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: • EuroQoL Questionnaire • Patient Treatment Satisfaction Questionnaire • Pittsburgh Sleep Questionnaire
研究者
Manisha Joshi
Scientific
Chelsea And Westminster Hospital NHS Foundation Trust
研究点 (1)
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