feature photo

 

Press Releases and Other Research News

New study suggests risk of birth defects in babies born to women who were taking dolutegravir at time of conception

May 18, 2018

Preliminary results from an ongoing observational study in Botswana indicate that infants of HIV-infected women taking dolutegravir (DTG) at the time of conception may be at increased risk of neural tube defects. The same study provides no evidence of an increased risk among infants born to women who initiated DTG treatment during pregnancy. Several organizations have issued statements related to these findings, as listed and linked below.

The safety of IMPAACT study participants is of paramount importance to the network and our collaborating partners. The network leadership, including our NIH partners, and the protocol teams for IMPAACT studies of DTG are actively discussing appropriate actions to be taken in response to the new findings. More information and relevant materials will be shared with the sites conducting these studies as soon as decisions are made. In the meantime, any questions should be directed to the respective protocol chairs.

• World Health Organization (WHO): http://www.who.int/medicines/publications/drugalerts/Statement_on_DTG_18May_2018final.pdf?ua=1

• European Medicines Agency (EMA): http://www.ema.europa.eu/ema/index.jsp?

• United States Food and Drug Administration (US FDA): https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm

• United States President’s Emergency Plan for AIDS Relief (PEPFAR): https://www.pepfar.gov/press/releases/282221.htm

• United States Health and Human Services (HHS) Antiretroviral Guidelines Panels: https://aidsinfo.nih.gov/news/2094/statement-on-potential-safety-signal-in-infants-born-to-women-taking-dolutegravir


Study results for IMPAACT P1078 presented at CROI 2018

March 7, 2018

P1078_CROI2018

The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is delighted to announce the presentation of the study results and important findings from IMPAACT P1078 (TB APPRISE), a phase IV, randomized, double-blind, placebo-controlled trial to evaluate the safety of immediate versus deferred isoniazid preventive therapy (IPT) among HIV-infected women in high tuberculosis (TB) incidence settings, at the 2018 annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts.

Read More


Late Breaker Accepted CROI 2018 Abstracts

CROI2018 February 6, 2018

The IMPAACT Network is pleased to announce that one late breaker abstract was accepted as an oral presentation in addition to 11 abstracts as posters and 2 abstracts as oral presentations have been accepted at the 25th Annual Conference on Retroviruses and Opportunistic Infections (CROI). To view the full listing, click here.

Updated 13 March: See all IMPAACT posters and presentations at CROI 2018

 


VESTED/IMPAACT 2010 Now Enrolling!

2010January 19, 2018

The IMPAACT Network is thrilled to report that the first participants have enrolled into VESTED/IMPAACT 2010, as of 19 January 2018. Congratulations to the St. Mary’s and Seke North sites (30303 and 30306) in Zimbabwe for leading the way!

NIAID has also issued a press release related to VESTED beginning enrollment, which can be accessed at this link.


Reflections on the Past year

WAD2017December 1, 2017

A World AIDS Day Message from IMPAACT Chair Sharon Nachman and IMPAACT Vice-Chair James McIntyre with a recap of 2017 Network milestones. Read here.

 

 


FDA Approves Labeling Changes for Raletegravir Based on Data from IMPAACT P1110

November 28, 2017

P1110

On 22 November 2017, the US Food and Drug Administration (FDA) approved labeling changes for Isentress (Raltegravir) – a potent and selective HIV-1 integrase inhibitor – based on IMPAACT P1110 Data - expanding the patient population to include HIV-exposed full term neonates (birth to 4 weeks of age and weighing at least 2 kg). IMPAACT P1110 is an ongoing Phase I, open label, non-comparative dose-finding study of HIV-1 exposed full-term neonates assessed as at risk of acquiring HIV-1 infection and their mothers. The study is designed to evaluate the safety and tolerability of raltegravir oral granules for suspension when administered during the first 6 weeks of life with standard ARV prophylaxis for prevention of vertical HIV transmission. Expanding the limited ARV options for neonates and infants is a key priority for the IMPAACT Network, and we are pleased with the FDA’s announcement here.

Merck Press Release



Accepted CROI 2018 Abstracts

November 28, 2017

The IMPAACT Network is pleased to announce that 11 abstracts as posters and 2 abstracts as oral presentations have been accepted at the 25th Annual Conference on Retroviruses and Opportunistic Infections (CROI). To view the full listing, click here.


Upcoming Deadlines for Conference Abstract Submissions

November 6, 2017

25th Conference on Retroviruses and Opportunistic Infections (CROI 2018)
The 25th Conference on Retroviruses and Opportunistic Infections (CROI) will be held in Boston, MA, from March 4 to 7, 2018. The conference deadline for late breaker abstract submission is Tuesday, January 16, 2018. The deadline for submission of Late Breaker Abstracts for IMPAACT review is Tuesday, 2 January 2018 by 5:00 pm ET.

 For more information, please visit the CROI website: http://www.croiconference.org/.

22nd International AIDS Conference (AIDS 2018)
The 22nd International AIDS Conference (AIDS 2018) will be held in Amsterdam, Netherlands, from July 23 to 27, 2018. The conference deadline for abstract submission is Monday, February 5, 2018. Additional conference deadlines are provided below for reference. The deadline for submission of general abstracts for IMPAACT review is Monday, January 22, 2018, by 5:00 pm ET.

 For more information, please visit the AIDS website: http://www.aids2018.org/.

Amsterdam



>> Read more from previous years in our News Archive

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.