2024-515265-34-00招募中4 期
Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The primary endpoint is the amount of intact replication competent HIV sequences at W48 quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.
研究概览
简要总结
The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in HIV-1 infected individuals in terms of the amount of intact replication-competent HIV-1 sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.
研究设计
- 分配方式
- Randomized
- 主要目的
- A Prospective Randomized Controlled Switch Trial.
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Ability and willingness to provide written informed consent
- •Ability to attend the complete schedule of assessments and patient visits
- •Ability and willingness to have blood samples collected and stored indefinitely and used for various research purposes
- •HIV RNA < 50 copies/mL for at least 3 months on a 2nd generation integrase inhibitor (INSTI) based regimen
- •Females of childbearing potential should be on effective contraception
排除标准
- •Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification).
- •Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance.
- •Creatinine Clearance <
- •Tuberculosis treatment.
- •Documented M184V.
- •Previous virological failure >200 copies/mL on NRTI.
- •Subjects with history or presence of allergy to any of the study drugs or their components.
- •ALT >5 times the ULN, OR ALT >3xULN and bilirubin >1.5xULN (with >35% direct bilirubin).
- •Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (seroconversion= HBV antigen or viral load negative and positive HBV surface antibody).
- •Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry.
- •Pregnancy or breastfeeding.
- •Patients unable to understand the study protocol or any other condition that in the investigator’s opinion may compromise compliance with the study protocol.
- •Decompensated liver cirrhosis (Child-Pugh B/C) Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
- •Psychiatric and psychological disorders, which in the opinion of the investigator, will interfere with the trial conduct or safety of the participant.
- •Previous participation in a trial evaluating an immune modulating agent.
- •Active drug or alcohol use/addiction such that, in the opinion of the site investigator, would interfere with adherence to study requirements.
结局指标
主要结局
The primary endpoint is the amount of intact replication competent HIV sequences at W48 quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.
The primary endpoint is the amount of intact replication competent HIV sequences at W48 quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.
次要结局
- Quantification of viral markers as total and intact HIV DNA, and RNA transcripts at baseline, W48, W144 and W240.
- Full length sequencing of the virus at baseline, W144 and W240.
- Quantification of human pro-inflammatory mediators and markers of microbial translocation at baseline, W48, W144 and W240.
- Phenotype of innate immune cells at baseline W48, W144, W240.
- Function of immune cells at baseline,W144 and W240.
- Metabolic parameters at baseline, W24, W48, W72, W96, W120,W144, W186, W192, W216 and W240.
- Analysis of cardio-vascular risk at W240 based on risk stratification at D0, W48 and W144 in all or a subgroup of individuals.
研究者
Sophie Degroote
Scientific
Universitair Ziekenhuis Gent
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Pilot study, open label, multicenter, evaluating dual antiretroviral therapy with long-acting cabotegravir/lenacapavir IMEA 069 - CALENDULA2024-516028-33-01Inst Medecine Epidemiologie Appliquee30
尚未招募
1/2 期
DORAL2024-513941-35-00Centre de Recherches et d’Etudes sur les Pathologies Infectieuses, Tropicales et le VIH/Sida118
已完成
4 期
Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric VulnerabilitiesHIV InfectionsNCT05549180Fundacion SEIMC-GESIDA84
已完成
3 期
评价 dolutegravir 在一线治疗失败的 HIV-1 感染者的安全性和抗病毒活性CTR2015035030
招募中
4 期
Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients with Chronic hepatitis Dhepatitis D2023-504414-29-00Karolinska University Hospital400