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临床试验/EUCTR2019-004435-23-PT
EUCTR2019-004435-23-PT进行中（未招募）1 期

A Phase IIb, randomized, partially blind, active controlled, dose-range finding study of GSK3640254 compared to a reference arm of dolutegravir, each in combination with nucleoside reverse transcriptase inhibitors, in HIV-1 infected antiretroviral treatment-naive adults - A Phase 2b Dose-Range Finding Clinical Trial in HIV-1 Infected Treatment-Naive Adults

ViiV Healthcare UK Limited0 个研究点目标入组 161 人开始时间: 2020年7月14日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
161
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •-Participants must be 18 years of age inclusive, at the time of signing the informed consent.
  • •-Treatment-naïve, defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection (e.g., use of PreP meets inclusion);
  • •-Documented HIV infection and Screening plasma HIV-1 RNA =1000 copies/mL;
  • •-Screening CD4+ T-cell count =350 cells/mm3;
  • •-Body weight =50.0 kg (110 lbs.) for men and =45.0 kg (99 lbs) for women and body mass index (BMI) > 18.5 kg/m2.
  • •-Male and female
  • •*NOTE: There are no contraceptive requirements for male participants.
  • •a. Female Participants
  • •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical
  • •-A female is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
  • •-Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4 of the protocol, Contraceptive and Barrier Guidance;
  • •-Is a WOCBP (as defined in Section 10.4 of the protocol) and using an acceptable contraceptive method as described in Section 10.4.2 during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for
  • •contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention.
  • •-If a hormonal method is selected, the female participant is required to be clinically stable on it for at least one month prior to starting
  • •treatment in the study.
  • •-A WOCBP must have a negative highly sensitive serum pregnancy test 42 days before the first dose of study intervention. See Section 8.2.5
  • •Pregnancy Testing.
  • •-Additional requirements for pregnancy testing during and after study intervention are located in Section 8.2.5.
  • •-The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a
  • •woman with an early undetected pregnancy.
  • •-Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • •-For participants enrolled in France: a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 190
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 20

排除标准

  • •-Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage
  • •3 disease [CDC, 2014], except cutaneous Kaposi’s sarcoma not requiring systemic
  • •-Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma,
  • •or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or
  • •penile intraepithelial neoplasia;
  • •Note: Other localized malignancies require agreement between the investigator
  • •and the ViiV Medical Monitor for inclusion.
  • •-Presence of primary HIV-1 infection, evidenced by acute retroviral syndrome (e.g.,
  • •fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented
  • •viremia without antibody production and/or evidence of recent (within 3 months)
  • •documented seroconversion;
  • •-Known history of liver cirrhosis with or without viral hepatitis co-infection;
  • •-Unstable liver disease (as defined by any of the following: presence of ascites,
  • •encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or
  • •persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of
  • •Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver
  • •disease per investigator assessment)
  • •-History of ongoing or clinically relevant hepatitis within the previous 6 months;
  • •-History of sensitivity to any of the study medications or their components or drugs of
  • •their class, or a history of drug or other allergy that, in the opinion of the Investigator
  • •or Medical Monitor, contraindicates their participation;
  • •-Any history of significant underlying psychiatric disorder, in the opinion of the
  • •Investigator or ViiV Medical Monitor, including but not limited to schizophrenia,
  • •bipolar disorder with or without psychotic symptoms, other psychotic disorders, or
  • •schizotypal (personality) disorder;
  • •-Any history of major depressive disorder with or without suicidal features, or
  • •anxiety disorders, that required medical intervention (pharmacologic or not) such as
  • •hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient
  • •Note: Participants with other conditions such as adjustment disorder or dysthymia
  • •that have required shorter term medical therapy (<6 months) without inpatient
  • •treatment and are currently well-controlled clinically or resolved may be
  • •considered for entry after discussion and agreement with the ViiV Medical
  • •-Any pre-existing physical or other psychiatric condition (including alcohol or drug
  • •abuse), which, in the opinion of the Investigator or ViiV Medical Monitor (with or
  • •without psychiatric evaluation), could interfere with the participant’s ability to
  • •comply with the dosing schedule and protocol evaluations or which might
  • •compromise the safety of the participant;
  • •-A pre-existing condition, in the opinion of the Investigator or ViiV Medical Monitor,
  • •that could interfere with normal gastrointestinal anatomy or motility (e.g.,
  • •gastroesophageal reflux disease [GERD], gastric ulcers, gastritis, inflammatory
  • •bowel disease), hepatic and/or renal function, or with the absorption, metabolism,
  • •and/or excretion of the study drugs or render the participant unable to take oral study
  • •-Myocardial infarction in the past 3 months;
  • •-Familial or personal history of long QT syndrome;
  • •-Medical history, current or historical, of significant cardiac arrhythmias or ECG
  • •findings which, in the opinion of the Investigator or ViiV Medical Monitor, will

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