SOLICITATION NOTICE
A -- NICHD PEDIATRIC AND PERINATAL HIV STUDIES NETWORK
- Notice Date
- 11/16/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Westat (NINDS PRIME CONTRACTOR), 1650 Research Blvd., Rockville, MD, 20850, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- WESTAT-7735-0602
- Response Due
- 1/31/2007
- Archive Date
- 2/15/2007
- Description
- BRIEF BACKGROUND Since 1992, Westat, a contract research organization located in Rockville, Maryland, has served as the coordinating center for the National Institute of Child Health and Human Development (NICHD) Pediatric and Perinatal HIV Studies Network under contract to NICHD. The coordinating center subcontracts with clinical sites to form the multi-center NICHD Pediatric and Perinatal HIV Studies Network. This Network consists of domestic and international clinical sites that conduct clinical studies related to treatment and prevention of HIV infection and its complications in infants, children, adolescents and pregnant women, observational HIV studies and selected clinical trials of gender-specific manifestations of HIV infection in non-pregnant women. Clinical studies are conducted within the NICHD Network primarily but not solely in collaboration with the International Maternal, Pediatric, and Adolescent AIDS Clinical Trials (IMPAACT) Group funded by the National Institute of Allergy and Infectious Diseases (NIAID) and NICHD. The IMPAACT Scientific committees, in conjunction with the Network Executive Committee (NEC), set the scientific agenda for therapeutic research in children and pregnant women in the U.S. and abroad. These Committees consist of investigators from IMPAACT, NIAID- and NICHD-funded HIV clinical trials sites, and staff from DAIDS/NIAID and PAMA/NICHD. Additionally, NICHD has developed collaborations outside of IMPAACT such as with the Pediatric European Network for Treatment of AIDS (PENTA), HIV Prevention Trials Network (HPTN), and the Adolescent Trials Network (ATN) to permit the addition of special expertise to answer specific research questions. Westat and the Network have participated in over 120 multi-center phase I through IV clinical trials in HIV-exposed and infected infants, and HIV-infected children, adolescents, and pregnant and non-pregnant women. The current coordinating center contract expires October 31, 2007. Westat has been directed by NICHD to conduct a competitive solicitation of clinical sites for participation in the Network in anticipation that NICHD will continue to support the network of clinical centers in the conduct of HIV studies in these populations. As the demographics of pediatric and maternal HIV infection have changed over time, the NICHD Network has expanded and modified the number and type of clinical trials sites that form the Network as well as the types of studies being done within the Network. Initially under this contract, the Network sites included a specialized obstetric component for the conduct of perinatal trials. In 1996 there was a competitive solicitation for new sites with an emphasis on sites with large pediatric/maternal populations that did not have access to clinical trials, and in 1997 the entire NICHD Network underwent a review prior to the coordinating contract recompetition. In recognition of the global nature of the pediatric and maternal HIV epidemic, the NICHD began an international expansion in 1998 in mid-developing countries in the Caribbean and Latin America, funding 5 sites in Brazil and 1 in the Bahamas. In 2002, all domestic NICHD-funded clinical sites were recompeted. Currently, the domestic Network consists of 29 centers located in 18 cities in 11 states/territories (including Puerto Rico). This Westat-initiated RFP intends to evaluate domestic and international sites for the NICHD Pediatric and Perinatal HIV Studies Network. Current sites that wish to continue participation in the NICHD Network under the new NICHD contract and potential new sites that have evidence of prior participation in NIH sponsored HIV clinical research studies such as Pediatric AIDS Clinical Trial Group (PACTG)/IMPAACT, NICHD International Site Development Initiative (NISDI), ATN, HPTN perinatal studies (including HPTN040) and Comprehensive International Program of Research on AIDS (CIPRA) studies may respond to this RFP. Clinical sites participate in the Network as subcontractors to the prime contractor. They are funded through a fixed price budget that is negotiated annually based on the actual and projected numbers of subjects to be enrolled in protocols and the work to be performed. GOALS/RESEARCH OBJECTIVES The primary goals of the NICHD Pediatric and Perinatal HIV Studies Network and this RFP include: Evaluating and developing improved interventions to further reduce mother-to-child HIV transmission, particularly for women who are identified very late in pregnancy or at labor and therefore have not received antiretrovirals; Evaluating the pharmacokinetics and safety of antiretroviral drugs in pregnant, infected women and their neonates, including metabolic and short- and long-term effects of exposure on the women and their infants; Identifying optimal strategies for timing therapy initiation in antiretroviral-na?ve infants, children, and adolescents; determining when to change therapy in those who are antiretroviral-experienced; and finding optimal treatments for those failing therapy; Identifying therapies that improve the clinical status, quality of life, and survival of HIV-infected infants, children, and adolescents at all stages of disease, from early asymptomatic infection to end-stage AIDS, including antiretroviral drugs, therapies aimed at reconstitution, and use of therapeutic HIV vaccines; Identifying therapies or prophylactic regimens that prevent or mitigate the development of serious sequelae of pediatric and adolescent HIV infection, including opportunistic infections, growth abnormalities, neurologic /neurodevelopmental impairments and other complications; Evaluating the long-term impact of antiretroviral therapy on HIV-infected infants, children, and adolescents, including morbidity and survival, with a particular emphasis on metabolic toxicities; Identifying and evaluating gender-specific manifestations of HIV and identifying therapies to treat women-specific manifestations in HIV-infected, non-pregnant women; and Evaluating the pathogenesis of HIV disease in children and women, and that of perinatal transmission in the context of clinical trials. NOTICE OF INTENT TO SUBMIT A PROPOSAL Proposal applicant institutions are requested to complete the Notice of Intent to Submit a Proposal form which is included with this RFP and return it by e-mail or fax to Steven Sokolowski at the address listed on the form by 5:00 p.m. U.S. Eastern Standard time on Friday December 15, 2006. Although a Notice of Intent is not required, is not binding, and is not part of the review of a subsequent proposal, the information that it contains allows Westat staff to estimate the potential review work involved and avoid conflict of interest in the review process.
- Record
- SN01182128-W 20061118/061116220327 (fbodaily.com)
- Source
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