PACTR202607711608317进行中（未招募）3 期
Switching to long-acting cabotegravir + lenacapavir during pregnancy: a non-inferiority trial of pragmatic test-and-treat-then-switch in late pregnancy and postpartum.
Africa Clinical Research Network0 个研究点目标入组 630 人开始时间: 2026年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 630
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
- 18 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnancy and HIV diagnosis
- •Pregnant woman aged =18 years (or =16 years where the country-specific appendix authorises; see country appendices).
- •Confirmed intrauterine pregnancy by transabdominal ultrasound prior to randomisation.
- •Gestational age 14–32 weeks (inclusive) at randomisation, dated by best-obstetric-estimate.
- •Confirmed HIV-1 infection per the protocol-specified diagnostic algorithm.
- •Detectable plasma HIV-1 RNA at screening, defined as HIV-1 RNA =50 copies/mL by central-laboratory assay reviewed before Day 0 randomisation. (Qualified point-of-care viral-load platforms may be used for internal triage or QC but do not replace central confirmation for randomisation.)
- •ART history
- •ART-naive first-time HIV diagnosis at the antenatal-entry visit, OR no prior antiretroviral exposure documented in clinic records or self-report; OR
- •Previously on ART but off ART for =28 calendar days at the time of screening, regardless of reason for prior discontinuation. Prior virologic failure does not disqualify. Capacity and consent
- •Willing and able to provide informed consent (or assent with co-consent per the country-specific appendix for ages 16–17 where applicable).
- •Willing to attend study visits and complete contacts per the Schedule of Activities, including the Day -3, Day 0, Day +1, Day +7, and Day +14 initiation-period requirements where applicable.
- •Willing to receive long-acting injections (CAB intramuscular and LEN subcutaneous) if randomised to the investigational arm.
排除标准
- •Active opportunistic infection requiring inpatient care or systemic therapy at screening.
- •Known hypersensitivity to cabotegravir, lenacapavir, tenofovir, lamivudine, or dolutegravir.
- •Current use of a prohibited concomitant medication (Section 6.11.1).
- •Grade 3 or higher renal impairment (eGFR <30 mL/min/1.73 m² by CKD-EPI) at screening.
- •Grade 3 or higher hepatic impairment (ALT or AST >5× upper limit of normal) at screening.
- •Active hepatitis B or hepatitis C infection requiring antiviral therapy that is incompatible with the assigned regimen.
- •Multiple gestation (=2 fetuses) where the obstetric care plan precludes participation in the protocol.
- •Major fetal anomaly identified at the screening or baseline ultrasound that in the investigator's judgement warrants exclusion.
- •Active substance use disorder uncontrolled by treatment that the investigator judges incompatible with safe study participation.
- •Concurrent enrolment in another investigational drug or device trial.
研究者
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