EUCTR2018-002208-15-IT进行中（未招募）1 期
A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults. - Ph 2a, GSK3640254, POC in HIV-1 infected Treatment-naive Adults
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
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 are eligible to be included in the study only if all of the following criteria apply:
- •1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •2.Participants who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring.
- •3.Screening CD4+ T-cell count >=350 cells/mm3
- •4.Documented HIV infection and Screening plasma HIV-1 RNA >=5000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.
- •5.Treatment-naïve: No ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
- •6.Body weight >=50.0 kg (110 lbs.) for men and >=45.0 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
- •7.Male or female:
- •a.Male participants:
- •A male participant with a female partner of child-bearing potential or who is breastfeeding or pregnant must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment phase and for at least 14 weeks following the last dose (corresponding to the time needed to eliminate study treatment for potential genotoxic and teratogenic study treatments plus an additional 90 days [spermatogenesis cycle]). In addition, male participants must refrain from donating sperm during this period.
- •b.Female participants:
- •A female participant is eligible to participate if she is not pregnant (see Appendix 5 of protocol ), not breastfeeding, and not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of protocol.
- •Informed Consent
- •8.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and stated in the protocol.
- •9.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.
- •10. Participant must be willing and able to start cART on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise)
- •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 34
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Presence of Hepatitis B surface antigen at screening or within 3 months prior to starting study treatment
- •2.Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment AND positive on reflex to Hepatitis C RNA
- •3. ALT >2 ULN.
- •4.Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •5.Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
- •6.A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease [GERD], gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study treatment
- •7.Any acute laboratory abnormality at screen which, in the opinion of the investigator, should preclude participation in the study of an investigational compound
- •8.Any Grade 2-4 laboratory abnormality at Screen, with the exception of creatine phosphokinase (CPK) and lipid abnormalities, and ALT (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor
- •9.Any pre-existing physical or psychiatric condition, which, in the opinion of the investigator, 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
- •10.Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome
- •11.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
- •12.The participant has participated in a clinical trial and has received an investigational product within the 30 days prior to the first dosing day in the current study.
- •13.Any positive (abnormal) response confirmed by the investigator on a Screening clinician- (or qualified designee-) administered C-SSRS
- •14.Any positive result for illicit drug use at Screening. A positive screen for marijuana is not exclusionary
- •15.Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
- •16.Exposure to more than four new investigational drugs or vaccines within 12 months prior to the first dosing day.
- •17.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or anticipated need for such treatment within the study.
- •18.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; or other localized malignancies require agreement between the investigator and the study medical monitor for inclusion of the subject prior to randomization.
- •19.Treatment with immunomodulating agents or any agent with known anti-HIV activity within 30 days of study drug administration.
- •20.An active CDC Category C disease except cutaneous Kaposi’s sarcoma not requiring systemic therapy during the trial.
- •21.Treatment with any vaccine within 30 days prior to receiving study medication.
研究者
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