Accomplishments: 

The year 2007 is the second year of the International Maternal Pediatric Adolescent AIDS Clinical Trials group – IMPAACT. It has been another year of transition, as individuals from the former Pediatric AIDS Clinical Trials Group (PACTG) and the HIV Prevention Trials Network (HPTN) joined with others from the United States and other countries to make IMPAACT a clinical trials network conducting effective, relevant trials to prevent and treat HIV infection among infants, children, adolescents, and their mothers. Outstanding investigators have been recruited to network leadership positions and major policies and procedures have been developed and implemented.

 In 2007, IMPAACT achieved a number of organizational milestones, including establishing an organizational structure and implementing policies that are functioning well scientifically and administratively to advance the scientific agenda into clinical trials; establishing a budget process for allocation of protocol implementation funds (PIF) to sites; developing two additional network standard operating procedures (SOPs), issuing more than 17 master subcontracts, initiating the development of 227 task orders, and finalizing the formation of resource and standing committee structures. Every effort was made to foster accountability, transparency, inclusiveness, fairness, and productivity.

 Collaborations:

 The network receives significant support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in terms of leadership group funding, scientific expertise, and the inclusion of clinical trial sites.

 The network has strived to foster and sustain collaborative relationships with multiple HIV/AIDS research and funding organizations: 

• National Institute of Drug Abuse (NIDA)
• National Institue of Mental Health (NIMH)
• Adolescent Trials Network (ATN)
• AIDS Clinical Trials Group (ACTG)
• HIV Prevention Trials Network (HPTN)
• HIV Vaccine Trials Network (HVTN)
• Pediatric European Network for Treatment of AIDS (PENTA).

Evaluation: 

During the second year, priority has been given to evaluating performance and assessing accountability at all levels of the network and to planning the mechanisms that will ensure that each structural component of the network operates efficiently and effectively to support the development and implementation of the group’s scientific agenda.

Sites:

The scope of pediatric, adolescent, and maternal health HIV/AIDS research has extended beyond the United States to include international investigators and clinical research sites. IMPAACT has been working with 35 international and 36 domestic clinical research sites (CRSs) to carry out the group’s research priorities.

Community:

The involvement of the community of HIV-affected individuals and families has been a critical component in the ongoing success of IMPAACT. The contributions of the community, both locally and globally, are critical for our network to significantly advance IMPAACT’s scientific agenda and advance the care of mothers, children, and adolescents. A new community organization now includes three levels of participation – community/site, regional, and network (IMPAACT).

Scientific Accomplishments:

IMPAACT ensures utilization of the best scientific expertise from its members and adds further benefits to its programs by involving individuals from its geographically diverse membership; it achieves this by selecting both senior and junior U.S. and international investigators to scientific committee positions. Sixteen capsules and 11 concept sheets were submitted by the scientific committees to the SOC/NEC for potential review and prioritization. IMPAACT has published 28 original research articles, and 33 manuscripts have been submitted for review since February 2007. Key findings include reports on the long-term complications of HIV infection, pharmacokinetics of new antiretroviral drugs and their interactions in children and pregnant women, the drug resistance profiles generated by specific antiretroviral regimens, and the dynamics of drug resistance fading in mothers and children exposed to single-dose nevirapine.
 

Enrollment and Subjects on Study:

From February 16, 2007, through February 15, 2008, the IMPAACT network enrolled 2533 women, children, and adolescents (1616 into 11 IMPAACT trials at international sites and 917 into nine IMPAACT trials in the United States). Of those enrolled, 2031 were enrolled into interventional trials, which is a 70% increase over the same period last year. The network has followed 2819 participants on study at international sites and 3990 participants at U.S. sites. Two new protocols were opened to accrual (P1065 and P1066), requiring a total enrollment of 424 participants.

The network has 13 open protocols, with 11 protocols and four concept sheets in development. Ten new protocols are planned to open by December 1, 2008 (P1063, P1068s, P1069, P1070, P1071, P1072, P1073, P1074, P1075, P1076), requiring a total of 4058 participants.
 

Looking Forward:

The top priorities as we move forward are evaluating strategies to minimize antenatal/intrapartum HIV transmission in a cost-effective manner; evaluating new interventions to allow infants to safely breastfeed and wean without dying or becoming HIV-infected; evaluating the benefits and risks to maternal health of stopping or continuing highly active antiretroviral therapy (HAART) after pregnancy; and evaluating new drugs and vaccines for the prevention and treatment of HIV and its complications. Because of the vast increase of HIV among pregnant women and children in developing countries, IMPAACT resource allocation will predictably shift toward supporting the international agenda. IMPAACT has been at the forefront of highly successful prevention of mother-to-child transmission (PMTCT) research and is planning a major new initiative (PROMISE) that targets outstanding domestic and international issues. At the same time, a number of critically important Phase I/II studies of promising drugs and vaccines, laboratory studies, and treatment strategy trials will comprise a robust domestic agenda and will continue to be conducted in the United States.