EUCTR2017-002946-62-DE进行中（未招募）1 期
A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed - Phase 3b study of Cabotegravir LA + Rilpivirine LA administered every 8 weeks or every 4 weeks, HIV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,049
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. Aged 18 years or older (or =19 where required by local regulatory agencies), at
- •the time of signing the informed consent.
- •2. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies:
- •a. Non-reproductive potential defined as:
- •- Pre-menopausal females with one of the following:
- •Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- •-Hysterectomy
- •-Documented Bilateral Oophorectomy
- •-Postmenopausal defined as 12 months of spontaneous amenorrhea [in
- •questionable cases a blood sample with simultaneous follicle stimulating
- •hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on
- •hormone replacement therapy (HRT) and whose menopausal status is in
- •doubt will be required to use one of the highly effective contraception
- •methods if they wish to continue their HRT during the study. Otherwise,
- •they must discontinue HRT to allow confirmation of post-menopausal
- •status prior to study enrolment.
- •b. Reproductive potential and agrees to follow one of the options listed in the
- •Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of
- •Reproductive Potential (FRP) from 30 days prior to the first dose of study
- •medication, throughout the study, for at least 30 days after discontinuation of all
- •oral study medications, and for at least 52 weeks after discontinuation of CAB LA
- •and RPV LA.
- •The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.
- •3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
- •Eligible participants or their legal guardians (and next of kin when locally
- •required), must sign a written Informed Consent Form before any protocol specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local
- •legal/regulatory requirements and site feasibility to conduct protocol procedures.
- •4. Participants enrolled in France must be affiliated to, or a beneficiary of, a social
- •security category.
- •5. Must be on uninterrupted current regimen (either the initial or second ARV
- •regimen) for at least 6 months prior to Screening. Any prior switch, defined as a
- •change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA =400 c/mL).
- •Acceptable stable (initial or second) ARV regimens prior to Screening include 2
- •NRTIs plus:
- •INI (either the initial or second cART regimen)
- •NNRTI (either the initial or second cART regimen)
- •Boosted PI (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability)
- •The addition, removal, or switch of a drug(s) that has been used to treat HIV
- •based on antiretroviral properties of the drug constitutes a change in ART with the following limited exceptions:
- •Historical changes in formulations of ART drugs or booster
排除标准
- •1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement = 50 c/mL
- •2. Within the 6 to 12-month window prior to Screening, any plasma
- •HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA
- •measurements = 50 c/mL
- •3. Any drug holiday during the window between initiating first HIV ART
- •and 6 months prior to Screening, except for brief periods
- •(less than 1 month) where all ART was stopped due to tolerability
- •and/or safety concerns
- •4. Any switch to a second line regimen, defined as change of a single
- •drug or multiple drugs simultaneously, due to virologic failure to
- •therapy (defined as a confirmed plasma HIV-1 RNA measurement
- •=200 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen)
- •5. A history of use of any regimen consisting of only mono or dual HIV-1
- •therapy (even if only for peri-partum treatment).
- •6.Participants who are currently
- •participating in or anticipate to be selected for any other interventional study with the exception of the 201585 (ATLAS) study.
- •7. During participation in ATLAS, consecutive (2 or more sequential)
- •plasma HIV-1 RNA measurements = 50 c/mL
- •8. During participation in ATLAS, any HIV-1 RNA measurement = 200 c/mL
- •9. More than two total measurements of plasma HIV-1 RNA = 50 c/mL
- •during participation in the ATLAS trial will require direct approval by
- •the ATLAS-2M Medical Monitor and Study virologist for study participation.
- •10. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
- •11. Any evidence of a current Center for Disease Control and Prevention
- •(CDC) stage 3 disease [CDC, 2014], except cutaneous Kaposi’s sarcoma
- •not requiring systemic therapy, and CD4+ counts <200 cells/µL are not exclusionary.
- •12. Participants with moderate to severe hepatic impairment
- •13. Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
- •14. Participants determined by the Investigator to have a high risk of
- •seizures, including participants with an unstable or poorly controlled
- •seizure disorder. A participant with a prior history of seizure may be
- •considered for enrolment if the Investigator believes the risk of
- •seizure recurrence is low. All cases of prior seizure history should be
- •discussed with the Medical Monitor prior to enrolment
- •15. All participants will be screened for syphilis. Participants with
- •untreated secondary (late latent) or tertiary syphilis infection,
- •defined as a positive RPR and a positive treponemal test without clear
- •documentation of treatment, are excluded. Participants with a false
- •positive RPR (with negative treponemal test) or serofast RPR result
- •(persistence of a reactivenontreponemal syphilis test despite history of
- •adequate therapy and no evidence of re-exposure) may enroll after
- •consultation with the Medical Monitor. Participants with primary syphilis
- •or early latent secondary syphilis (acquiredwithin the preceding year)
- •who have a positive RPR test and have not been treated may be treated
- •during the screening period and if completion of antibiotic treatment
- •occurs during the screening period, may be allowed entry after
- •consultation with the Medical Monitor. Ifantibiotic treatment cannot be
- •completed before the screening window en
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