跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2017-002946-62-SE
EUCTR2017-002946-62-SE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

ViiV Healthcare UK Limited0 个研究点目标入组 1,049 人开始时间: 2017年10月18日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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
研究概览入排标准研究者记录与标识符相似试验

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 drugs will not
  • •constitute a chang

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 reactive
  • •nontreponemal 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 (acquired
  • •within 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. If antibiotic treatment cannot be
  • •completed before the screening window ends, subjects may be rescreened once
  • •following completi

研究者

相似试验

进行中（未招募）
1 期
207966 or ATLAS-2M is a study to compare two drugs called Cabotegravir and Rilpivirine when given as long acting injections either every 8 weeks or every 4 weeks in adults with HIV.Human Immunodeficiency Virus type 1 (HIV-1)MedDRA version: 20.1Level: LLTClassification code 10003582Term: Asymptomatic human immunodeficiency virus type I infectionSystem Organ Class: 100000004862
EUCTR2017-002946-62-ITVIIV HEALTHCARE UK LIMITED1,049
进行中（未招募）
1 期
Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every 8 weeks in Virologically Suppressed HIV-1-infected Adults.Human Immunodeficiency Virus type 1 (HIV-1)MedDRA version: 20.1Level: LLTClassification code 10003582Term: Asymptomatic human immunodeficiency virus type I infectionSystem Organ Class: 100000004862
EUCTR2017-002946-62-DEViiV Healthcare UK Limited1,049
进行中（未招募）
1 期
207966 or ATLAS-2M is a study to compare two drugs called Cabotegravir and Rilpivirine when given as long acting injections either every 8 weeks or every 4 weeks in adults with HIV.Human Immunodeficiency Virus type 1 (HIV-1)MedDRA version: 20.0Level: LLTClassification code 10003582Term: Asymptomatic human immunodeficiency virus type I infectionSystem Organ Class: 100000020183
EUCTR2017-002946-62-ESViiV Healthcare, S.L.850
招募中
4 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral TherapyHIV infections
JPRN-jRCT2051230132Kajiwara Makoto412
已完成
3 期
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
JPRN-jRCT2080223432GlaxoSmithKline K.K.631