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A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV

预防艾滋病毒孕妇疟疾和性传播感染的新疗法

基本信息

批准号：
9766109
负责人：
Jodie Ann Dionne
金额：
$ 16.74万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-23 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9766109
关键词：
Address Adherence Africa Africa South of the Sahara African Anemia Antibiotics Antigens Antimalarials Area Award Azithromycin Biometry Birth Blood CD4 Lymphocyte Count Cameroon Central Africa Cessation of life Chlamydia trachomatis Clinical Sciences Conduct Clinical Trials Country Data Development Directly Observed Therapy Disease Dose Epidemiology Falciparum Malaria Fetal Growth Retardation Goals HIV Human Subject Research Immunity Infant Infection Infection prevention Intervention Knowledge Late pregnancy Low Birth Weight Infant Low Prevalence Macrolide Antibiotics Malaria Malaria prevention Manuscripts Measures Mentors Microscopy Modeling Monitor Neisseria gonorrhoeae Neonatal Newborn Infant Nucleic Acid Amplification Tests Outcome Parasitemia Parasites Participant Patients Perinatal Perinatal Epidemiology Perinatal Infection Perinatal mortality demographics Peripheral Pharmaceutical Preparations Phase Pregnancy Pregnant Women Premature Birth Preparation Prevalence Prevention Prophylactic treatment Pyrimethamine-Sulfadoxine Questionnaires Randomized Randomized Controlled Trials Regimen Reporting Research Research Project Grants Resistance Resources Risk Risk Factors Safety Scientist Sepsis Serious Adverse Event Sexually Transmitted Diseases Streptococcus Group B Swab Syphilis Syphilis Serodiagnosis Techniques Testing Training Translational Research Treponema pallidum Trimethoprim-Sulfamethoxazole Vagina Vertical Disease Transmission Visit Vulnerable Populations Woman Women&apos s Group World Health Organization adverse pregnancy outcome arm co-infection cost density design efficacy testing experience fetal follow-up hands-on learning improved improved outcome innovation malaria infection maternal morbidity medication compliance medication safety neonatal morbidity novel novel therapeutics open label parity pathogen pathogenic bacteria perinatal outcomes phase II trial prenatal testing prevent prophylactic randomized trial skills standard of care stillbirth success symposium transmission process treatment arm treatment as usual usual care arm young woman

项目摘要

Project Summary/Abstract Pregnant women with HIV in Africa have high rates of coinfection with malaria and sexually transmitted infections (STIs) that contribute to adverse maternal and birth outcomes including stillbirth, preterm delivery, low birth weight and vertical transmission of HIV. Malaria prophylaxis improves maternal and perinatal outcomes but current regimens are limited by emerging resistance and serious interactions with medications that are used in patients with HIV. The identification of a novel drug regimen with dual prevention for both malaria and curable bacterial STIs in pregnancy would be an important innovation toward improved outcomes in this vulnerable group of women and infants. To address this pressing problem, this K23 application describes the background and experience of the applicant, Jodie A. Dionne-Odom, MD and her plan to acquire the knowledge and training necessary to become an independent, leading scientist in the prevention and treatment of coinfections in HIV-infected pregnant women in sub-Saharan Africa. Her K23 training objectives are to: (1) develop expertise in the design and conduct of clinical trials in resource-limited settings (2) gain advanced training in epidemiology and biostatistics including perinatal epidemiology, drug safety monitoring and infection modeling techniques; (3) acquire skills in measuring malaria and STI endpoints and (4) gain additional training in performing human subjects research and grant and manuscript preparation. To meet these objectives, a comprehensive training plan has been developed in concert with an interdisciplinary team of mentors and consultants who are established senior research experts. The plan includes hands-on learning, coursework leading to an MSPH in Clinical and Translational Science and supplemental short courses and conferences. Equipped with this training, Dr. Dionne-Odom will conduct research to test whether a novel combination prophylactic regimen of trimethoprim-sulfamethoxazole (TMPS) and azithromycin (AZ) is superior to the current standard malaria prophylaxis (TMPS) and whether it has the added benefit of reducing STI prevalence. In Specific Aim 1, a phase II randomized controlled trial will be performed to test the efficacy of the combination prophylaxis regimen TMPS-AZ compared to TMPS in HIV-infected pregnant women. The primary efficacy outcome will be a decrease in the peripheral malaria parasite load at delivery. In Specific Aim 2, the prevalence of treatable bacterial STIs after 35 weeks gestation (or delivery) will be measured and compared between both arms. In Specific Aim 3, the fetal/neonatal safety and adherence/tolerability of the combination regimen will be determined. Data from this phase II trial will be used to support an R-01 phase III multicenter randomized controlled trial in sub-Saharan Africa. The training acquired from this award in combination with results from this project will facilitate the successful transition of Dr. Dionne-Odom to research independence and success.

项目总结/文摘