This year's World AIDS Day theme is “Equalize,” with a call to action to address inequalities in the HIV/AIDS epidemic.
Dear IMPAACT Network Colleagues,
On this World AIDS Day, we would like to reflect on the achievements of the Network in the past year and recognize the contributions of our members and supporters. This year's World AIDS Day theme is “Equalize,” with a call to action to address inequalities in the HIV/AIDS epidemic. Addressing these inequalities is central to the IMPAACT Network as evidenced by our fundamental commitment to conduct HIV research in infants, children, adolescents, and pregnant and postpartum people. We are so thankful for the ongoing dedication and resilience of our site staff, study participants, and the support of their communities over this past year.
IMPAACT has continued our collaborations with the World Health Organization (WHO) as well as with our other NIH-supported HIV research networks to encourage cross-collaboration and expanded research among the key populations that IMPAACT aims to serve. Notably, IMPAACT colleagues and the WHO supported a new special issue with the Journal of the International AIDS Society entitled, “Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy.” IMPAACT colleagues, as part of the NIH/DAIDS Cross-Network Tuberculosis Working Group, also published a paper in Lancet recommending that people living with HIV must be included in clinical trials for new tuberculosis vaccine candidates currently in the development pipeline.
Data from two IMPAACT studies contributed to two successful updates to the United States Food and Drug Administration (US FDA) approvals of ARVs in children. Based on data from IMPAACT 2014, the US FDA approved doravirine and a fixed-dose combination of doravirine/lamivudine/tenofovir disoproxil fumarate for treatment of HIV in children weighing 35 kg or greater. The European Medicines Agency approved a similar extension, expanding the current indication to include adolescents aged 12 years and older weighing at least 35 kg. Read more. Based on interim data from IMPAACT 2017, the US FDA approved cabotegravir/rilpivirine for the treatment of HIV-1 in adolescents who are virologically suppressed, 12 years of age or older, and weigh at least 35 kg. This approval marks the first time a long-acting HIV treatment is available for the adolescent population. Read more.
In the past year, the IMPAACT Network has had other notable achievements:
In January, the PrEP Comparison Component of IMPAACT 2009 was opened, following the successful completion of the PK Component. IMPAACT 2009 is a two-part trial evaluating the feasibility, acceptability, and safety of oral PrEP in pregnant and postpartum adolescents and young women (16 to 24 years of age) in sub-Saharan Africa.
In February, the IMPAACT 2028 team announced the first enrollment for the study. IMPAACT 2028 is an observational study to characterize a cohort of children who may participate in future research related to HIV remission or cure.
Also in February, the IMPAACT Network presented data at the Conference on Retroviruses and Opportunistic Infections from IMPAACT P1107. The IMPAACT P1107 Protocol Team presented the first known case of a woman with HIV remission following a stem cell transplant for treatment of acute myelogenous leukemia (AML). The transplant consisted of cord blood stem cells with the CCR5Δ32 genetic mutation and haploidentical peripheral blood stem cells from a relative. Read more. The Network also presented results at CROI from 16 additional abstracts from 12 studies, for a total of three oral presentations and 14 poster presentations.
In April, follow-up in IMPAACT 2032 was completed. IMPAACT 2032 was a Phase IV pharmacokinetic (PK) study of remdesivir in pregnant and non-pregnant women of childbearing potential for treatment of COVID-19. It was the first study of the pharmacology of any COVID-19 treatment in pregnancy.
In June, many of us met in-person or virtually at the IMPAACT Annual Meeting, in Washington DC. Over 650 in-person and virtual attendees from 24 countries converged over four days for plenary sessions, protocol meetings, and roundtable discussions. See the presentations and other materials here.
In September, the IMPAACT Social Behavioral Scientific Core (SBSC) initiated a SpotLight Series, with successful webinars in September and October, featuring moderated panels and keynote speakers sharing research and expertise related to socio-behavioral science. Learn more.
In October, enrollment in IMPAACT 2023 was initiated. IMPAACT 2023 is a Phase I study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1. The study had opened to accrual in September.
As this year comes to a close and we honor World AIDS Day, we are grateful for the many contributions of our clinical research site staff, community members, investigators, study participants and their caregivers/parents, central Network staff, committee and protocol team members, pharmaceutical collaborators, sponsors, and other Network partners. It is through your efforts that the IMPAACT Network continues our critical work to “equalize” and address inequalities by evaluating interventions in infants, children, adolescents, and pregnant and postpartum people.
Best wishes to all for a happy and safe new year!
Sharon Nachman, IMPAACT Chair
Patricia Flynn, IMPAACT US Vice Chair
Philippa Musoke, IMPAACT International Vice Chair