2025-524336-19-00招募中3 期
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 183
- 试验地点
- 54
- 主要终点
- Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as defined by the US FDA snapshot algorithm.
研究概览
简要总结
To evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral SBR in virologically suppressed PWH as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
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
- •Participants assigned male or female at birth, 18 years of age or older at screening, able to understand and give written informed consent and comply with treatment and follow-up.
- •Participants assigned female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.
- •Medical History/Physical Characteristics MH
- •Body weight ≥ 35 kg at screening.
- •HIV-1 susceptibility results from screening meeting specific criteria: Proviral phenotypic susceptibility to both TAB and ZAB by the investigational PhenoSense HIV mAb Assay (Labcorp Monogram Biosciences) at screening. TAB phenotypic susceptibility is defined as IC90 ≤ 2 µg/mL; ZAB phenotypic susceptibility is defined as IC90 ≤ 2 µg/mL.
- •Plasma HIV-1 RNA levels < 50 copies/mL at screening (SV2).
- •At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+ 2 months) prior to screening (SV1). This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and < 400 copies/mL (transient detectable viremia or “blips”) prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is < 50 copies/mL.
- •A plasma HIV-1 RNA test < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to SV
- •If > 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be < 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- •On a stable oral ART for ≥ 6 months prior to screening. A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than VF (eg, tolerability, simplification, DDI profile) is allowed; participants with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be < 50 copies/mL. There are no permitted changes to ART regimens between SV1 and Day
- •Laboratory Assessments LA1.For participants of childbearing potential, a negative serum pregnancy test at screening, prior to Day 1 randomization, and enrollment (per Appendix 11.4). A negative urine pregnancy test is required on Day 1 visit prior to the dosing of study drugs.
排除标准
- •Medical Conditions/History MC
- •History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
- •Prior/Concurrent Therapy or Clinical Study Experience PT
- •Prior use of, or exposure to, LEN or a bNAb for HIV-
- •Prior use of, or exposure to, ibalizumab fostemsavir, or maraviroc.
- •Baseline regimen consisting of monotherapy with any single ARV.
- •Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.
- •Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3.
- •Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
- •Prior use of, or exposure to, LA injectable CAB or LA injectable RPV.
- •Current use of, or exposure to, nevirapine or zidovudine.
- •Diagnostic Assessments DA
- •Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
- •Chronic HBV infection, as determined by either: Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit. Note: Participants found to be susceptible to HBV infection (eg, negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive an HBV vaccination. Those who remain non immune will receive regular testing for HBV.
- •Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.
- •Severe renal impairment-estimated glomerular filtration rate < 30 mL/min according to the Cockcroft-Gault formula {Cockcroft 1976}.
- •Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.B10
- •Any of the following laboratory values at screening: A) Alanine aminotransferase > 5 × upper limit of normal (ULN). B) Direct bilirubin > 1.5 × ULN. C) Platelets < 50,000/mm
- •D) Hemoglobin < 8.0 g/dL.
- •Other Exclusion Criteria E
- •Have other concurrent medical or psychiatric conditions, or prior therapies that, in the investigator’s opinion,B10may be likely to confound study interpretation, prevent completion of study procedures and follow-up examinations, or poses an undue risk to the participant.
- •Participants under guardianship, curatorship, or legal protection may not participate in the study.B10
- •Active, serious infections (other than HIV-1) requiring therapy < 30 days prior to randomization.
- •Active tuberculosis infection.
- •Acute hepatitis of any cause < 30 days before randomization.
- •History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).
- •Active malignancy requiring acute systemic therapy.
- •Have poor venous access that would limit phlebotomy or IV infusion of study drugs.
- •Participants assigned female sex at birth who are pregnant, nursing a child (breastfeeding), or plan to become pregnant, or begin nursing (breastfeeding) a child during the study.
研究组 & 干预措施
Epivir 150 mg film-coated tablets
Comparator
干预措施: Epivir 150 mg film-coated tablets (Drug)
Pifeltro 100 mg film-coated tablets
Comparator
干预措施: Pifeltro 100 mg film-coated tablets (Drug)
Tybost 150 mg film-coated tablets
Comparator
干预措施: Tybost 150 mg film-coated tablets (Drug)
INTELENCE 200 mg tablets
Comparator
干预措施: INTELENCE 200 mg tablets (Drug)
Sunlenca 300 mg film-coated tablets, Sunlenca 464 mg solution for injection
Test
干预措施: Sunlenca 464 mg solution for injection (Drug)
Ziagen 300 mg film-coated tablets
Comparator
干预措施: Ziagen 300 mg film-coated tablets (Drug)
REZOLSTA 800 mg/150 mg film-coated tablets
Comparator
干预措施: REZOLSTA 800 mg/150 mg film-coated tablets (Drug)
ISENTRESS 400 mg film-coated tablets
Comparator
干预措施: ISENTRESS 400 mg film-coated tablets (Drug)
REKAMBYS 600 mg prolonged-release suspension for injection
Comparator
干预措施: REKAMBYS 600 mg prolonged-release suspension for injection (Drug)
Tivicay 50 mg film-coated tablets
Comparator
干预措施: Tivicay 50 mg film-coated tablets (Drug)
Genvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets
Comparator
干预措施: Genvoya 90 mg/90 mg/120 mg/6 mg film-coated tablets (Drug)
Sunlenca 300 mg film-coated tablets, Sunlenca 464 mg solution for injection
Test
干预措施: Sunlenca 300 mg film-coated tablets (Drug)
Norvir 100 mg powder for oral suspension
Comparator
干预措施: Norvir 100 mg powder for oral suspension (Drug)
Viread 123 mg film-coated tablets
Comparator
干预措施: Viread 123 mg film-coated tablets (Drug)
EFAVIRENZ VIATRIS 600 mg, comprimé pelliculé
Comparator
干预措施: EFAVIRENZ VIATRIS 600 mg, comprimé pelliculé (Drug)
REYATAZ 200 mg hard capsules
Comparator
干预措施: REYATAZ 200 mg hard capsules (Drug)
Emtriva 200 mg hard capsules
Comparator
干预措施: Emtriva 200 mg hard capsules (Drug)
Aptivus 250 mg soft capsules
Comparator
干预措施: Aptivus 250 mg soft capsules (Drug)
GS-2872
Test
干预措施: GS-2872 (Drug)
GS-5423
Test
干预措施: GS-5423 (Drug)
结局指标
主要结局
Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as defined by the US FDA snapshot algorithm.
Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 as defined by the US FDA snapshot algorithm.
次要结局
- Incidence of ADAs and neutralizing antibodies (NAbs) of TAB and ZAB.
- Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 92 as defined by the US FDA snapshot algorithm.
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 52 and 92 as determined by the US FDA snapshot algorithm.
- Changes from baseline in CD4+ T-cell counts at Weeks 52 and 92.
- Proportion of participants experiencing TEAEs.
- Proportion of participants prematurely discontinuing their study treatment due to an AE.
- Trough concentrations at Weeks 26, 52, and 104 for LEN, TAB, and ZAB.
研究者
EU CT Support
Scientific
Gilead Sciences Inc.
研究点 (54)
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