Maternal HIV Drug Resistance Is Associated with Mother-to-Child Transmission

NIAID Now |

Antiretroviral therapy of pregnant women and antiretroviral treatment of infants have greatly reduced the rate of mother-to-child HIV transmission, also referred to as vertical transmission. Nevertheless, although these improved rates have occurred in some countries, vertical transmission rates remain relatively high in others. This may be due to multiple factors, including access to testing, care and antiretroviral therapy, adherence to antiretroviral therapy during pregnancy and breastfeeding, and potential HIV drug resistance. In order to evaluate the factors that result in vertical transmission, researchers compared variables that resulted in HIV outcomes in infants from pregnant and breastfeeding mothers from 14 sites in 7 countries.

The researchers analyzed plasma from mothers and their infants at or near the time of infant HIV diagnosis to determine whether their infections were resistant to currently used drugs. Additionally, the researchers did long-term analysis of the HIV genetic structure in the infants so that they could analyze possible drug resistance later on. Their findings showed that maternal HIV drug resistance was not associated with in utero vertical transmission. However, both maternal viral load and HIV drug resistance were associated with vertical transmission during breastfeeding. These findings support efforts to reduce and eliminate HIV reproduction during pregnancy and have implications for re-evaluating appropriate antiretroviral treatment for breastfeeding infants.

Reference: Boyce et al.  Maternal Human Immunodeficiency Virus (HIV) Drug Resistance Is Associated With Vertical Transmission and Is Prevalent in Infected InfantsClinical Infectious Diseases, 2021; ciab744.

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Still Time To Apply For Administrative Supplements on Women’s Health, Sex and Gender

Funding News Edition:
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Current grantees, take note: Over the next two weeks, applications are due for three distinct initiatives providing administrative supplements for research at the nexus of women’s health, sex and gender, and health disparity populations.

For each initiative, NIH published a notice of special interest (NOSI) and each NOSI directs applicants to apply through the funding opportunity announcement Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp, Clinical Trial Optional).

Notice Number NOSI Title Application Due Date
NOT-OD-22-032 Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp, Clinical Trial Optional) January 21, 2022
NOT-OD-22-030 Administrative Supplements for Research on Sex and/or Gender Influences (Admin Supp, Clinical Trial Optional) January 26, 2022
NOT-OD-22-031 Research on the Health of Women of Understudied, Underrepresented and Underreported (U3) Populations (Admin Supp, Clinical Trial Optional) January 31, 2022

Regardless of the NOSI through which you apply, you must include the corresponding notice number in the Agency Routing Identifier field (box 4B) of the SF 424 (R&R) Form.

Remember: administrative supplements require that the supported research be within the approved scope of an ongoing award. Before applying, we strongly encourage you to discuss with the program officer assigned to your ongoing award whether your proposed supplement is within scope.

As our article “Understand Scope and Why It Matters for Managing Your Grant” explains, if the study you propose is beyond the aims, objectives, and purposes of your current grant, you should apply for a competitive revision rather than an administrative supplement.

Administrative Supplements for Research on SGM Populations

The NOSI will fund projects to enrich scientific understanding of how sexual orientation, gender identity, or being born with differences/disorders in sex development or intersex characteristics relate to health outcomes, health risks, health behaviors, perceptions and expectations about health, and access to health-related services or associated barriers.

For example, you might expand an ongoing study focused on one SGM group to add another or you could conduct secondary analysis of existing data to generate new information or hypotheses about SGM health.

Request only one year of support and limit your budget request to $100,000 in total costs.

Administrative Supplements for Research on Sex and/or Gender Influences

Apply if you’re capable of research at the basic, preclinical, translational, or clinical level to address at least one objective from the five strategic goals of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research: Research, Methods, Dissemination and Implementation, Training and Careers, or Evaluation. Paramount is addressing the role of sex or gender in health and disease.

Potential topics include the influence of sex and gender on disease incidence, prevention, treatment, and reoccurrence; or gender roles influencing caretaking responsibilities, and effects on health, resilience, and disease.

Request only one year of support and limit your budget request to $100,000 in direct costs.

Research on the Health of Women of U3 Populations

This initiative supports preclinical, clinical, behavioral, and translational projects highlighting common sources of disparities in women and girls’ health with a specific emphasis on those that integrate measures beyond the individual level and consider perspectives from multiple disciplines. You are encouraged to incorporate multilevel interventions using community-engaged approaches and focusing on one or more NIH-designated Health Disparity Populations.

Projects you could propose range from broad explorations of caretaking responsibilities, systemic barriers to participation, gender discrimination, and social and structural determinants of health inequities to narrow investigations of risk factors associated with COVID-19 disease prevalence among underserved and underrepresented populations of women.

Request only one year of support and limit your budget request to $140,000 in direct costs.

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Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

NIH Begins Study of COVID-19 Vaccination During Pregnancy and Postpartum

A new observational study has begun to evaluate the immune responses generated by COVID-19 vaccines administered to pregnant or postpartum people. Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk. 

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Vaginal Ring for HIV Prevention Receives Positive Opinion from European Regulator

Newer Anti-HIV Drugs Safest, Most Effective During Pregnancy

The antiretroviral drugs dolutegravir and emtricitabine/tenofovir alafenamide fumarate (DTG+FTC/TAF) may comprise the safest and most effective HIV treatment regimen currently available during pregnancy, researchers announced today. Their findings come from a multinational study of more than 640 pregnant women with HIV across four continents. The study results affirm updated recommendations for HIV treatment in pregnant women set forth by the World Health Organization (WHO).

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NIH Study Finds Lower Concentration of PrEP Drug in Pregnant Young Women

Among African adolescent girls and young women who took HIV pre-exposure prophylaxis (PrEP) daily, levels of the PrEP drug tenofovir were more than 30% lower in those who were pregnant than in those who had recently given birth. All 40 study participants took PrEP under direct observation, confirming their near-perfect adherence. PrEP drug levels were lower to a similar degree in the pregnant African adolescent girls and young women compared to American men and non-pregnant, non-lactating women who took PrEP daily under direct observation in an earlier study.

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NIH-Funded Clinical Trial to Test PrEP, Dapivirine Ring for Safety in Pregnant Women

The first clinical trial specifically designed to test the safety of the monthly dapivirine vaginal ring in pregnant women has begun in southern and eastern Africa. The National Institutes of Health-funded study also will test the safety of a daily oral antiviral tablet for HIV pre-exposure prophylaxis (PrEP) in pregnant women and will assess how much they accept and use these two HIV prevention tools. The study will complement an ongoing NIH-funded trial of PrEP in adolescents and young women during pregnancy and the first six months after birth.

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New Multiple Sclerosis Treatment Trial Compares Stem Cell Transplantation to Best Available Drugs

A clinical trial has begun testing an experimental stem cell treatment against the best available biologic therapies for severe forms of relapsing multiple sclerosis (MS). The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will compare the safety, efficacy and cost-effectiveness of the two therapeutic approaches. 

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Autoimmunity Centers of Excellence (ACE)

NIAID established the Autoimmunity Centers of Excellence (ACE) in 1999 to conduct collaborative basic and clinical research on autoimmune diseases. The ACE program enables close interaction between clinicians and basic researchers to accelerate the discovery, development, and translation of therapies for autoimmune diseases from the lab to use in the clinic. The program has been renewed multiple times, most recently in fiscal year 2024. 

Read more about this network: Autoimmunity Centers of Excellence (ACE)

Main Areas of Focus

  • To encourage and enable collaborative research – across scientific disciplines, across medical specialties, and between basic and clinical scientists – in the search for effective treatments for autoimmune diseases
  • To evaluate the safety and efficacy of treatment strategies for autoimmune diseases
  • To explore the immune mechanisms underlying efficacy of agents evaluated in these ACE clinical trials

Currently Funded Projects

The ACE program includes five U19 cooperative agreements supporting basic research and three UM1 cooperative agreements conducting clinical trials in autoimmune disease.

Basic Research Projects

A Mechanistic Understanding of B Cell and Macrophage Plasticity in Lupus Disease Activity States
Feinstein Institute for Medical Research
Principal Investigator: Anne Davidson and Betty Diamond
Award Number: U19AI144306

An Autoimmune Center of Excellence for the Study of IgG4-Related Disease
Massachusetts General Hospital
Principal Investigator: Shiv Subramaniam Pillai
Award Number: U19AI110495

Identifying New Immunotherapeutic Targets for Endocrine Autoimmunity
University of California, Los Angeles
Principal Investigator: Maureen A. Su
Award Number: U19AI181729

Immune Cells and Secretory Pathways Leading to Human Systemic Autoimmunity
Weill Medical College of Cornell University
Principal Investigator: Maria Virginia Pascual
Award Number: U19AI144301

Regulation of B cell Responses in SLE and Other Autoimmune Diseases
Emory University
Principal Investigator: Ignacio E. Sanz
Award Number: U19AI110483

Clinical Projects

Johns Hopkins Autoimmunity Center of Excellence
Johns Hopkins University
Principal Investigator: Julie Jisun Paik
Award Number: UM1AI181725

Oklahoma ACE: Molecular Destruction of Autoimmune Disease to Aid Clinical Trail Success
Oklahoma Medical Research Foundation
Principal Investigator: Judith A. James
Award Number: UM1AI144292

Targeting T Cell Subsets in Autoimmune Disease
Massachusetts General Hospital
Principal Investigator: John H. Stone
Award Number: UM1AI144295

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Microbicide Trials Network (MTN)

The Microbicide Trials Network (MTN) is an NIAID-funded worldwide collaborative clinical trials network focused on preventing the sexual transmission of HIV.

Read more about this network: Microbicide Trials Network

Main Areas of Focus

  • To bring together international investigators and community and industry partners whose work is focused on the development and rigorous evaluation of promising microbicides
  • To develop dual purpose products that would offer women a means for both HIV protection and contraception

Oversight

The Leadership and Operations Center (LOC) has primary responsibility for the administration of funds to clinical research sites (CRSs) as well as providing logistical and administrative support to the MTN Executive Committee (EC), and other MTN committees and working groups. The EC is the primary governance body of the MTN and is responsible for the overall scientific direction, development and implementation of policy, procedural decisions and resource allocation.

Contact Information

Locations

204 Craft Avenue
Pittsburgh, PA 15213

Events

MTN holds regional meetings and an annual network-wide meeting.

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Content Manager