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Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women (PREDUAL)

2026年9月15日 更新者：Maria Ines Figueroa、Fundación Huésped

Evaluating the Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in ART-Naïve Pregnant Women

Protocol Number: FH-94

Study Objetives:

Primary:

  • To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.

Secondary:

  • To evaluate the incidence of maternal adverse events.
  • To evaluate perinatal outcomes at delivery.
  • To evaluate maximum virological suppression at delivery.
  • To evaluate the incidence of changes in body weight exceeding what is expected for gestation.
  • To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
  • Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF/XTC or DTG+TAF/FTC.
  • To evaluate the incidence of HIV infection in children that breastfeed.
  • To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC.

Exploratory:

  • To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
  • To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Primary endpoints:

  • Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
  • Proportion of children born without HIV infection at 6 weeks & 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months

Secondary endpoints:

  • Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum.
  • Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
  • Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
  • Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
  • Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
  • Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
  • Proportion of HIV infection among breastfed children.
  • Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms. Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit.

Exploratory endpoints:

  • Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
  • Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery.

Patient Population: HIV-1-infected Pregnant Women aged >16 years (>15 years for Brazil's sites) who are naïve to antiretroviral therapy Study design: Phase IV. Randomized, non-comparative, open-label, multicenter study.

Regimens: Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg or tenofovir alafenamide 25 mg/emtricitabine 200 mg.

Duration: 14 months approximately months (depending on gestational age at entry).

Sample size: 210 subjects

研究类型

介入性

注册 (估计的)

210

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 巴西
      • São Paulo、巴西、04037-030
        • 尚未招聘
        • RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution
        • 接触：
        • 首席研究员：
          • Ricardo Sobhie Diaz, MD
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、40110-160
        • 尚未招聘
        • Fundação Bahiana de Infectologia
        • 接触：
        • 接触：
        • 首席研究员：
          • Carlos Brites, MD
    • Pernambuco
      • Curitiba、Pernambuco、巴西、80430-000
        • 尚未招聘
        • Complexo do Hospital de Clínicas da UFPR/Ebserh
        • 接触：
        • 首席研究员：
          • Monica Maria Gomes da Silva, MD
    • Rio Grande do Norte
      • Natal、Rio Grande do Norte、巴西、59075-070
        • 尚未招聘
        • Universidade Federal do Rio Grande do Norte
        • 接触：
        • 首席研究员：
          • Monica Bay, MD
    • Rio de Janeiro
      • Nova Iguaçu、Rio de Janeiro、巴西、26030-380
        • 尚未招聘
        • Hospital Geral de Nova Iguaçu
        • 接触：
        • 首席研究员：
          • Aline Santos Ramalho Teixeira Benevenuto, MD
  • 阿根廷
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1155AHD
        • 招聘中
        • Hospital General de Agudos Dr. Cosme Argerich
        • 接触：
        • 首席研究员：
          • Diego Cecchini, MD
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1188AAF
        • 招聘中
        • Sanatorio Güemes
        • 接触：
        • 接触：
          • Sebastián Nuñez, MD
          • 电话号码：8384 / 8365 +54 11 4959-8200
          • 邮箱：snunez@fsg.edu.ar
        • 首席研究员：
          • Verónica Lacal, MD
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1425AGP
      • El Palomar、Buenos Aires、阿根廷、B1684
        • 尚未招聘
        • Hospital Nacional Profesor Alejandro Posadas
        • 接触：
        • 首席研究员：
          • Mariana Golikow, MD
      • Isidro Casanova、Buenos Aires、阿根廷、B1765
        • 尚未招聘
        • Hospital de Agudos Paroissien
        • 接触：
        • 接触：
        • 首席研究员：
          • Pablo Garnica, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

All persons who are eligible must meet all of the following:

  1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies/mL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA/EIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed.
  2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months.
  3. Ability to sign the informed consent form.
  4. Plasma HIV-1 RNA ≥1000 copies/mL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant.

6. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and/or ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center.

7. The participant intends to continue with the pregnancy.

Exclusion Criteria:

All eligible individuals must NOT meet any of the following criteria:

  1. Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K).
  2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).
  3. Hemoglobin <8 g/dL.
  4. Fetal abnormalities detected on ultrasound
  5. Concomitant medications required with possible drug interactions specified in section 5.10.
  6. ALT >=5 times the ULN, or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification
  7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl <50 mL/min, total bilirubin, ALT, or AST).
  8. Active opportunistic infection at screening: active severe opportunistic infections and/or severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry.
  9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures.
  10. Problematic drug and/or alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.
  11. Known allergy or sensitivity to any of the study medications or their formulations.
  12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications.
  13. Creatinine Clearance of <30 mL/min . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental

Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
药品：Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]

1 pill QD

其他名称：
  • BI-THERAPY
有源比较器：Active Comparator

TDF/XTC or TAF/FTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine)

  • TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
  • TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
  • TAF/FTC 25/200 MG, 1 tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
药品：TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)

1 pill of each QD

其他名称：
  • 三联疗法

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To evaluate the virological response to Dolutegravir/Lamivudine in pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates
大体时间：From enrollment to the end of treatment at 6 months after delivery

Endpoints:

  • Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
  • Proportion of children born without HIV infection at 6 weeks & 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months.
From enrollment to the end of treatment at 6 months after delivery

次要结果测量

结果测量
措施说明
大体时间
- To evaluate the incidence of adverse maternal events.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum
From enrollment to the end of treatment at 6 months after delivery
- To evaluate perinatal outcomes at delivery
大体时间：From enrollment to the end of treatment at 6 months after delivery

Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate maximum virological suppression at delivery
大体时间：From enrollment to the end of treatment at 6 months after delivery

Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation
大体时间：From enrollment to the end of treatment at 6 months after delivery

Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
From enrollment to the end of treatment at 6 months after delivery
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC, DTG+TDF/XTC or DTG+TAF/FTC.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of HIV infection in children that breastfeed.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Proportion of HIV infection among breastfed children
From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 1 of 2.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms.
From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 2 of 2
大体时间：From enrollment to the end of treatment at 6 months after delivery

Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit
From enrollment to the end of treatment at 6 months after delivery

其他结果措施

结果测量
措施说明
大体时间
- To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.
大体时间：From enrollment to the end of treatment at 6 months after delivery

Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery
From enrollment to the end of treatment at 6 months after delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fundación Huésped

合作者

ViiV Healthcare

调查人员

  • 首席研究员：Pedro Enrinque Cahn, MD、Fundación Huésped

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月10日

初级完成 (估计的)

2028年10月15日

研究完成 (估计的)

2028年10月15日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月27日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FH-94

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享时间框架

3 month after last patient last visit

IPD 共享访问标准

By request

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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