Pregnancy Outcomes and Infant Survival in the Era of Universal HAART in Africa
非洲普及 HAART 时代的妊娠结局和婴儿存活率
基本信息
- 批准号:9356899
- 负责人:
- 金额:$ 10万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-09-30 至 2018-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAfricaAfrica South of the SaharaAnti-Retroviral AgentsBirthBirth WeightBreast FeedingCD4 Lymphocyte CountCase Report FormCellsChildChild CareClinicalClinical TrialsComplexDataDeltastabDiseaseEnrollmentEpidemicEpidemiologic MethodsEvaluationFetal Growth RetardationFrequenciesGestational AgeGoalsGuidelinesHIVHealthHighly Active Antiretroviral TherapyHospitalsImmuneImmune systemImmunizationInfantInterventionKnowledgeLow Birth Weight InfantMalawiMaternal HealthMorbidity - disease rateMother-to-child HIV transmissionMothersObservational StudyOutcomePharmaceutical PreparationsPharmacotherapyPostpartum PeriodPregnancyPregnancy OutcomePremature BirthRandomizedRandomized Clinical TrialsRegimenResearchResearch InfrastructureRisk FactorsSafetySamplingSiteStagingUgandaViral Load resultVisitWater SupplyWomanWomen&aposs GroupZimbabweadverse pregnancy outcomebasecomparison groupexpectationexperiencefield studyfollow-uphealth differenceimprovedinfant morbidity/mortalitymortalityneonatal deathnovel strategiespregnantpublic health interventiontransmission processtreatment strategy
项目摘要
DESCRIPTION (provided by applicant): Globally, there is a renewed commitment to eliminate mother-to-child transmission (MTCT) of HIV. In Malawi, universal, lifelong combination antiretroviral treatment (ART) is recommended for all HIV-infected women who are pregnant, breastfeeding, or between pregnancies. In this approach, known as Option B+, combination ART is prescribed irrespective of a woman's immune status or stage of HIV clinical disease. Findings from a recent, large multisite randomized clinical trial known as PROMISE showed that combination ART can reduce rates of MTCT of HIV to very low levels (~0.5%). The efficacy results of the PROMISE trial support the 2013 WHO guidelines where use of combination ART was recommended. The PROMISE study also showed that some ART drugs may be associated with adverse pregnancy outcomes such as low birth weight (LBW) and preterm (PT) birth and may increase early neonatal death. While PROMISE did not randomize women to Malawi's specific Option B+ regimen, some drugs are common to both regimens. We propose an observational study with two specific aims that relate to safety findings from PROMISE. In Aim 1, we will compare pregnancy outcomes (LBW, PT and intrauterine growth restriction) between HIV-infected and HIV-uninfected women. Aim 2 will compare survival between HIV-exposed infants (born to HIV-infected mothers) and HIV-unexposed infants (born to HIV-uninfected mothers). Earlier studies that predated ART use in Africa showed substantial differences in pregnancy outcomes and infant survival among HIV-infected untreated women and their children compared to HIV-uninfected women and their children. These differences were attributed to HIV. The goal of the proposed study is to assess if universal ART, as in Option B+, has eliminated these differences. This is an urgent and important question. If substantial differences in pregnancy outcomes and survival associated with HIV still remain, other factors underlying these outcomes will need further examination. The proposed study is exploratory and will provide preliminary data to conceptualize larger studies to examine the complex causes of these outcomes - including safety of ARTs - and to determine if further interventions are needed. The study will be conducted in Blantyre, Malawi in the main hospital and several health centers. A total sample of 1350 women will be enrolled; 675 HIV-infected healthy women on Option B+ ART prior to or during pregnancy and 675 HIV-uninfected women. These women and their children will be prospectively followed postnatally for up to one year. Birth weight and gestational age will be assessed at birth and case reports forms will be completed at enrollment and each follow-up visit.
描述(由申请人提供):在全球范围内,有一个新的承诺,以消除母婴传播(MTCT)的艾滋病毒。在马拉维,建议所有感染艾滋病毒的孕妇、哺乳期妇女或两次怀孕之间的妇女普遍接受终身联合抗逆转录病毒治疗。在这种被称为选项B+的方法中,无论妇女的免疫状态或艾滋病毒临床疾病的阶段如何,都规定了联合抗逆转录病毒疗法。最近一项名为PROMISE的大型多地点随机临床试验的结果表明,联合抗逆转录病毒疗法可以将艾滋病毒母婴传播率降低到非常低的水平(约0.5%)。PROMISE试验的疗效结果支持2013年WHO指南,其中建议使用联合ART。PROMISE研究还表明,一些ART药物可能与不良妊娠结局有关,如低出生体重(LBW)和早产(PT),并可能增加早期新生儿死亡。虽然PROMISE没有将女性随机分配到马拉维特定的选项B+方案,但有些药物是两种方案所共有的。 我们提出了一项观察性研究,有两个特定的目标,与安全性的结果,从PROMISE。在目标1中,我们将比较HIV感染和未感染HIV妇女的妊娠结局(LBW、PT和宫内生长受限)。目标2将比较暴露于艾滋病毒的婴儿(由感染艾滋病毒的母亲所生)和未暴露于艾滋病毒的婴儿(由未感染艾滋病毒的母亲所生)的存活率。在非洲使用抗逆转录病毒疗法之前进行的早期研究表明,与未感染艾滋病毒的妇女及其子女相比,感染艾滋病毒的未治疗妇女及其子女的妊娠结局和婴儿存活率有很大差异。这些差异归因于艾滋病毒。拟议研究的目标是评估通用ART(如选项B+)是否消除了这些差异。这是一个紧迫而重要的问题。如果与艾滋病毒相关的妊娠结局和存活率仍然存在实质性差异,则需要进一步检查这些结局的其他因素。拟议的研究是探索性的,将提供初步数据,以概念化更大的研究,以检查这些结果的复杂原因-包括ART的安全性-并确定是否需要进一步干预。 该研究将在马拉维的布兰太尔的主要医院和几个健康中心进行。总共将入组1350名女性样本; 675名在妊娠前或妊娠期间接受选项B+ ART的HIV感染健康女性和675名未感染HIV的女性。这些妇女和她们的孩子将在出生后进行长达一年的前瞻性随访。将在出生时评估出生体重和胎龄,并在入组和每次随访访视时填写病例报告表。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('TAHA E TAHA', 18)}}的其他基金
Pregnancy Outcomes and Infant Survival in the Era of Universal HAART in Africa
非洲普及 HAART 时代的妊娠结局和婴儿存活率
- 批准号:
9150635 - 财政年份:2015
- 资助金额:
$ 10万 - 项目类别:
Training in HIV-related Non-communicable Disease Complications in Malawi
马拉维艾滋病毒相关非传染性疾病并发症培训
- 批准号:
8516197 - 财政年份:2013
- 资助金额:
$ 10万 - 项目类别:
Training in HIV-related Non-communicable Disease Complications in Malawi
马拉维艾滋病毒相关非传染性疾病并发症培训
- 批准号:
8723920 - 财政年份:2013
- 资助金额:
$ 10万 - 项目类别:
The Johns Hopkins University-Blantyre Clinical Trials Unit
约翰·霍普金斯大学布兰太尔临床试验中心
- 批准号:
8784174 - 财政年份:2007
- 资助金额:
$ 10万 - 项目类别:
The Johns Hopkins University-Blantyre Clinical Trials Unit
约翰·霍普金斯大学布兰太尔临床试验中心
- 批准号:
10057729 - 财政年份:2007
- 资助金额:
$ 10万 - 项目类别:
The Johns Hopkins University-Blantyre Clinical Trials Unit
约翰·霍普金斯大学布兰太尔临床试验中心
- 批准号:
10527349 - 财政年份:2007
- 资助金额:
$ 10万 - 项目类别:
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