EUCTR2019-003814-16-IT进行中（未招募）1 期
A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination with an Optimized Background Regimen in Heavily Treatment Experienced People Living with HIV-1 Infection with Multidrug Resistance - N/A
GILEAD SCIENCES INCORPORATED0 个研究点目标入组 100 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •1)Willing and able to provide written informed consent (participants >=18 years of age) and assent (participants >= 12 and < 18 years of age) prior to performing study procedures. For participants >=12 and < 18 years of age, parent or legal guardian willing and able to provide written informed consent prior to performing study procedures as required by local law
- •2)Adult aged >= 18 years (at all sites) or adolescent aged >= 12 and weighing >= 35 kg (at sites in North America and Dominican Republic)
- •3)Are receiving a stable failing ARV regimen for > 8 weeks before Screening and willing to continue the regimen until Day 1. Participants in Cohort 1 must also be willing to continue the failing regimen until completing the Functional Monotherapy Period (Day 1 to Day 14)
- •4)Have HIV 1 RNA >= 400 copies/mL at Screening
- •5)Have screening or available historical HIV resistance reports showing resistance to >= 2 antiretroviral medications from each of 3 of the 4 main classes of antiretroviral medications (NRTI, NNRTI, PI, INSTI). Resistance to FTC or 3TC associated with the presence of the M184V/I RT mutation cannot be used for the purpose of determining this eligibility criterion
- •6)Have <= 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen in the opinion of the investigator based on resistance, tolerability, contraindication, safety, drug access, or acceptability to the participant. Refer to Table 5 2 for list of disallowed ARVs
- •7)Able and willing to receive an optimized background regimen together with GS 6207. Participants with an OBR without a fully active agent may be enrolled if the investigator considers that there is a favorable risk-benefit ratio for the participant. With prior approval from Gilead Sciences, components of the OBR may be investigational (ie, not yet approved)
- •8)A negative serum pregnancy test is required for all women at Screening
- •9)Partecipants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4.
- •10)Lactating women must agree to discontinue nursing before administration of GS 6207
- •Are the trial subjects under 18? yes
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1)An opportunistic illness requiring acute therapy within the 30 days prior to screening
- •2)Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days before screening
- •3)Active tuberculosis infection
- •4)Acute hepatitis within 30 days prior to Screening visit
- •5)Untreated or newly treated (< 3 months prior to screening) Hepatitis B Virus (HBV) infection. Participants may be enrolled regardless of the HBV serology criteria below if they are receiving treatment with anti-HBV activity and plan to continue the treatment during the study. Hepatitis B infection is defined as screening results showing either or both of:
- •a.Positive HBV surface antigen
- •b.Positive HBV core antibody and negative HBV surface antibody. Participants may be enrolled with these findings if they have HBV DNA 6)Hepatitis C virus (HCV) antibody positive and HCV RNA > LLOQ
- •7)A history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
- •8)Treatment within three months prior to screening, or anticipated treatment during the study period with immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic chemotherapeutic agents without prior approval from Sponsor prior to randomization. Agents disallowed in Table 5 2 may not be considered for approval.
- •9)Active malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
- •10)Current alcohol or substance use judged by the Investigator to potentially interfere with the participant’s study compliance
- •11)Clinically significant abnormal ECG at the Screening visit
- •12)Any of the following laboratory values at screening:
- •a.Estimated GFR = 50 mL/min using Cockcroft-Gault formula for participants = 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age for creatinine clearance
- •b.ALT > 5 x upper limit of normal (ULN)
- •c.Direct bilirubin > 1.5 x ULN
- •d.Platelets < 50,000/mm3
- •e.Hemoglobin < 8.0 g/dL
- •13)Participation or planned participation in any other clinical trial (including observational trials) without prior approval from the sponsor throughout the study
- •14)Prior use of, or exposure to, GS-6207
- •15)Known hypersensitivity to the IMP, the metabolites, or formulation excipient
- •16)Use or planned use of exclusionary medications, refer to Section 5.4
- •17)Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
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