PACTR202302484199604尚未招募3 期
ong-Acting Treatment in Adolescents (LATA): A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa
niversity College London0 个研究点目标入组 460 人开始时间: 2023年1月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •1.HIV-1-positive
- •2.Aged 12-19 years
- •3.Aware of HIV status
- •4.Body weight =35Kg
- •5.On ART consisting of 2NRTI and a third agent
- •6.On ART for =1 year with no previous regimen change for treatment failure*
- •7.Virologically suppressed with all HIV-1 RNA viral loads <50copies/mL¥ in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mL¥ at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL
- •8.Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate
- •9.Written informed assent in participants aged 12 to 17 years
- •10.Females who are sexually active must be willing to adhere to highly effective methods of contraception¦
- •* Treatment failure includes virological, immunological or clinical failure where regimen has been changed for lack of response to treatment
- •¥ The screening sample VL must be <50 copies/mL. For samples prior to screening, a diluted sample may be used; if the viral load in the diluted sample is below lower limit of quantification (LLQ), a calculated VL<100 copies/mL is allowed; if the viral load in the diluted sample is equal or above LLQ the calculated VL should be below 50 copies/mL.
- •¦ Highly effective contraception are injectable, implantable, oral and intrauterine contraceptives which have an expected failure rate <1% per year; in the LA group, must avoid pregnancy for 12 months after the last dose of the CAB and RPV LA
排除标准
- •1.Known HIV-2 positive
- •2.Females who are pregnant or breastfeeding
- •3.Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial
- •4.Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale
- •5.Hepatitis B SAg positive
- •6.ALT =3 x upper limit of normal
- •7.On treatment for active TB
- •8.Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir
- •9.Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder
- •10.Unwilling or contraindication to receiving injections
- •11.Contraindication to receiving injectable agents in the buttock area
- •12.Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of the investigator precludes participation
- •13.Previous randomisation in the BREATHER Plus trial
- •14.Known major** resistance to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors
- •**Major NNRTI and INSTI mutations are those listed in the IAS report (www.iasusa.org/resources/hiv-drug-resistance-mutations/ - which is likely to change over time (36)
研究者
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