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News Archive

2016

IMPAACT P1093 Informs Committee for Medicinal Products for Human Use (CHMP) positive opinion to lower the age and weight limit for Tivicay® (dolutegravir) in children and adolescents living with HIV in Europe.

December 21, 2016

This CHMP positive opinion follows the U.S. Food and Drug Administration’s (FDA) paediatric approval in June 2016 of dolutegravir for a reduced age and weight limit. Read More

Sixteen IMPAACT Abstracts Accepted for CROI 2017

December 1, 2016

The IMPAACT Network is pleased to announce that 16 abstracts have been accepted at the 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) as posters. To view the full listing, click here.

RSV studies achieve robust enrollment

November 7, 2016

IMPAACT is pleased to report that IMPAACT 2011 successfully closed to accrual, and IMPAACT 2012 enrolled 51% of the target accrual before the start of the fall 2016 respiratory syncytial virus (RSV) season. IMPAACT 2011 and 2012 are the first two in a series of three new Phase I studies of the infectivity, safety, and immunogenicity of similar RSV vaccines. In spring 2017, IMPAACT 2012 is expected to complete enrollment, and the third study, IMPAACT 2013, is expected to open to accrual. These studies represent a continued collaborative effort of the IMPAACT network, the National Institutes of Health Laboratory of Infectious Diseases (NIH LID), and the Johns Hopkins University Center for Immunization Research (JHU CIR), and they follow prior collaborative protocols P1096, P1114, and IMPAACT 2000.

Publication of PROMISE Breastfeeding and Formula Feeding Versions Antepartum Results

November 7, 2016

The IMPAACT Network is pleased to announce the antepartum results from the PROMISE Breastfeeding and Formula Feeding Versions (1077BF and 1077FF) were published in the New England Journal of Medicine (NEJM). This part of the PROMISE study demonstrated that triple antiretroviral (ARV) regimens evaluated in the study were superior to the single ARV based regimen for prevention of perinatal transmission during pregnancy and immediately postpartum. Read More

PROMISE studies successfully closed to follow up

October 5, 2016

IMPAACT is pleased to announce that the Promoting Maternal and Infant Survival Everywhere (PROMISE) studies have successfully closed to follow-up. The PROMISE studies are a group of three multi-faceted trials and one sub-study designed to address - in an integrated and comprehensive fashion - critical questions facing HIV-infected pregnant and postpartum women and their infants, including evaluation of the optimal ARV strategies for prevention of antepartum, intrapartum, and postpartum perinatal transmission of HIV and the optimal strategy to preserve maternal health. The studies began in 2010 and included over 9000 mothers and infants across 65 clinical research sites in Africa, Asia, and the Americas. Results from portions of the studies were recently presented at AIDS 2016 and will soon be published in the New England Journal of Medicine.

Request for Applications (RFA)

August 12, 2016

The US National Institutes of Health (NIH)-sponsored International Maternal Pediatric Adolescent Clinical Trials (IMPAACT) Network aims to increase investigator access to and use of stored biological specimens available at both the National Institute of Allergy and Infectious Diseases (NIAID) Biomedical Research Institute (BRI) repository and the Fisher Scientific repository, both in Rockville, Maryland, for new laboratory-based scientific investigations. Read More

PROMISE at AIDS 2016

The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is delighted to announce the presentation of several important outcomes from the ongoing Promoting Maternal and Infant Survival Everywhere (PROMISE) study at the 21st International AIDS Conference and the preceding 8th International Workshop on HIV Pediatrics in Durban, South Africa. Read More

IMPAACT at AIDS 2016: Satellite Sessions, Posters, and Oral Presentations

TIES
  • 8th International Workshop on HIV Pediatrics, with four oral presentations and five posters, and TB 2016, with two posters
  • AIDS 2016 Satellite Session: HIV Prevention for Pregnant & Breastfeeding Women
  • AIDS 2016, with four oral presentations and three posters
See each of the posters and presentations here

IMPAACT P1093 Informs FDA Approval of Dolutegravir in Children and Adolescents

ViiV Healthcare announced in mid-June 2016 that the US Food and Drug Administration has approved a supplemental New Drug Application for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages 6 to less than 12 years old, for the treatment of HIV-1 in children and adolescents. This approval is based on 24-week data from the Phase I/II multi-center, open-label P1093 study conducted in collaboration with IMPAACT. See the full press release here.

TIES Study Underway

The Treating Infants Early Study (TIES) Study, an observational study of HIV-infected infants in the U.S. who initiate antiretroviral therapy (ART), is now underway.

OCSO Monitoring Operations Branch Report

Read the latest NIAID OCSO Monitoring Operations Branch report of 2015 here.

2015

Fifteen IMPAACT Abstracts Accepted for CROI 2016

The IMPAACT Network had 15 of its abstracts accepted at the 23rd Conference on Retroviruses and Opportunistic Infections (CROI) – two as oral presentations, two as posters and themed discussions, and ten as posters. To view the full listing, click here.

IMPAACT Early Career Investigator Award Recipients For 2015 Announced

The IMPAACT Network is pleased to announce the first group of IMPAACT Early Career Investigator Mentored Research Awardees. The awardees are Anne M. Neilan, David Bearden, and Florence Momplaisir. The program aims to support the development of early career investigators to enter the field of maternal/child HIV research and advance the mission of the IMPAACT Network. In coordination with team of mentors, early career investigators work on a project that takes advantage of data and/or samples generated by the IMPAACT Network over the course of 24 months. Read more.

2015 Annual Meeting

Presentations from the June 2015 Annual Meeting are available. Go to Presentations page.

2014

New ACTG and IMPAACT Specimen Repository Tool

The ACTG and IMPAACT leadership are pleased to announce the launching of a new website that provides public access to our networks’ specimen repository. The website is the result of collaborations between DAIDS, ACTG and IMPAACT to provide a tool to increase investigator access to NIAID and NICHD repository specimens from approved network studies.

NIAID Launches ClinRegs

The ClinRegs website is designed to help the research community explore clinical research regulations within specific countries and compare regulatory requirements across countries.

PROMISE Breastfeeding and Formula Feeding Versions Report Antepartum Results and Promise HAART Standard Version to Complete Accrual

The IMPAACT network and PROMISE study teams are pleased to report results from the Antepartum Components of the Breastfeeding and Formula Feeding Versions of the PROMISE study, in the linked message from the IMPAACT network leadership and press release from NIAID. In addition, we are pleased to announce that accrual into the the HAART Standard Version of the PROMISE study will close at the end of November.

We would like to take this opportunity to commend and thank the PROMISE study sites, as well as the many thousands of study participants, for their dedication and commitment, without which the achievements of the PROMISE study thus far would not have been possible. Follow-up in PROMISE will continue for approximately the next two and a half years to address some of the most important global public health questions related to prevention of mother-to-child transmission of HIV and maternal and infant health.

PROMISE Study Now Closed to Accrual

IMPAACT is pleased to announce that the breastfeeding version of the PROMISE Study (1077BF) is now closed to accrual!  Congratulations to all sites and staff who have contributed to the tremendous effort of enrolling over 3000 mother-infant pairs in this study.  Follow-up in PROMISE will continue for the next two years to address some of the most important global public health questions related to prevention of mother-to-child transmission of HIV and maternal and infant health.

DAIDS Launches New Learning Portal

DAIDS Portal Screen

Take an online course, get live assistance with your training needs, connect with your colleagues, and more. Find out more about the DAIDS Learning Portal here.

Merck Receives FDA Approval for Raltegravir for Pediatric Oral Suspension


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.