2024-515070-28-00招募中3 期
A Phase 3b, open label, randomized, standard-of-care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (CROWN)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 37
- 主要终点
- Virologic response (HIV 1 RNA <50 c/mL) using the Snapshot Algorithm at Month 6
研究概览
简要总结
To demonstrate a superior viral suppression rate after 6 months of CAB LA + RPV LA, administered every 2 months, compared with oral ART in treatment experienced PWH with viremia
研究设计
- 分配方式
- Randomized
- 主要目的
- Standard of care oral ART
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Aged at least 12 years old and weighting at least 35 kg
- •Documented HIV-1 infection with plasma HIV-1 RNA >1,000 and <100,000 c/mL
- •Evidence of insufficient virologic response to participant's current oral ART regimen (defined as participant having an active prescription) within 18 months before study entry according to at least 1 of the following criteria: i. <1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months. ii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs)
- •Currently being treated with/prescribed an oral ART regimen and willing to continue taking an oral ART regimen until after their Month 6 viral load result is available.
- •Participant (if aged 18+) or a participant's parent/legal guardian is able to give signed informed consent. Where applicable an adolescent participant is able to assent to participate in the study.
- •Staff study participants are eligible to participate if they are responsible for/involved in adherence support for CAB + RPV LA, are able to agree to and have the time to participate in interviews and questionnaire completion, and have the cognitive ability to complete questionnaires and take part in an interview that may take up to 60 minutes.
排除标准
- •HIV-1 subtype A6
- •Any previous use of CAB
- •Current or recent use of medications prohibited or defined as exclusionary in the protocol.
- •Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.
- •Current or anticipated participation in another interventional study.
- •Evidence of viral drug resistance to INSTIs or NNRTIs at Screening or in any historical resistance test result.
- •Has exclusionary safety laboratory test results at Screening
- •QTc >450 msec or >480 msec for participants with bundle branch block at Screening
- •Unwilling to receive injections or unable to receive gluteal injections.
- •Participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition in the gluteus region which may interfere with interpretation of injection site reactions.
- •Evidence of alcohol or substance use disorder within the previous 12 months, as assessed by the Investigator using standard methods for their site, that would interfere with the participant's safety.
- •Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study
- •Adolescents who are wards of the state.
- •Staff study participants will be excluded if they are not involved in adherence support for viremic patients on CAB + RPV LA or if they are unwilling to be audio recorded during the interviews.
- •Unstable liver disease or a history of liver cirrhosis with or without hepatitis viral co-infection.
- •Co-infection with Hepatitis B where they would not be able to receive appropriate therapy for their HBV co-infection or with Hepatitis C if they are currently receiving anti-HCV therapy at Day 1
- •Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
- •Participants with a high risk of seizures, including those with an unstable or poorly controlled seizure disorder.
- •High sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that contraindicates their participation.
- •Participants who pose a significant suicidality risk. History of suicidal behavior and/or suicidal ideation should be considered when assessing suicide risk.
- •Pre-existing physical or mental condition that may interfere with the participant's ability to comply with the dosing schedule and/or protocol assessments, or which may compromise participant safety.
结局指标
主要结局
Virologic response (HIV 1 RNA <50 c/mL) using the Snapshot Algorithm at Month 6
Virologic response (HIV 1 RNA <50 c/mL) using the Snapshot Algorithm at Month 6
次要结局
- Time to virologic suppression (HIV-1 RNA <50 c/mL) from baseline (Day 1) through Month 6
- Time to TRDF (PDVF or drug-related AE, intolerability of injections, protocol defined stopping criteria or lack of efficacy) from baseline (Day 1) through Month 6
- Protocol-defined VF through Month 6
- Occurrence of developing RAMs through Month 6
- Occurrence of developing INSTI or NNRTI RAMs through Months 12 and 24
研究者
EU GSK Clinical Trials Call Center
Scientific
Viiv Healthcare UK Limited
研究点 (37)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate Tobevibart+Elebsiran in Participants with Chronic HDV Infection Not Virologically Suppressed with Bulevirtide2024-519282-22-00Vir Biotechnology Inc.132
招募中
2 期
A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)2024-517140-65-00AbbVie Deutschland GmbH & Co. KG76
招募中
2 期
Study of Intravenous ABBV-400 in Combination With Intravenous Budigalimab to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC2024-514465-18-00AbbVie Deutschland GmbH & Co. KG105
招募中
3 期
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen2022-500929-33-01Gilead Sciences Inc., Gilead Sciences Inc., Gilead Sciences Inc.129
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