Notice Number: NOT-HD-07-008
Release Date: January 24, 2007
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
The National Institute of Child Health and Human Development (NICHD) requires logistical, technical, and administrative support to maintain, coordinate, and manage a multi-site network of clinical centers conducting research on treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease in pediatric, adolescent, and maternal patient populations, including both domestic and international clinical sites. The NICHD is announcing a competitive Request for Proposal for a Contractor to serve as the NICHD International and Domestic Pediatric and maternal HIV Clinical Studies Coordinating Center, which encompasses both clinical trials on the treatment and management of HIV infection in infants, children, adolescents, and pregnant and non-pregnant women domestically and internationally, including infrastructure development as well as clinical trials. The Coordinating Center contract currently encompasses several inter-related projects: the NICHD Network of clinical trials sites; the Latin American/Caribbean NICHD International Site Development Initiative (NISDI); a trial of post-exposure prophylaxis of HIV-exposed infants (NICHD/HPTN 040 Trial); the India Perinatal Project; and site monitoring for phase III investigator-initiated clinical trials. The current contractor for this effort is Westat, Inc.
Scope of Activities
Current activities conducted within the Coordinating Center contract include the following:
The NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network (“NICHD Network”) has been funded through the NICHD Coordinating Center contract since 1987. The NICHD Network consists of domestic and international clinical sites that enroll study subjects in trials related to preventing and treating HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women, as well as selected clinical trials of gender-specific manifestations of HIV infection in non-pregnant women. The Network enrolls into trials conducted by the Pediatric AIDS Clinical Trials Group (PACTG) and Adult ACTG funded by the National Institute of Allergy and Infectious Diseases (NIAID), the NICHD-funded Adolescent HIV Medicine Trials Network (ATN), and Pediatric European Network for Treatment of AIDS (PENTA). Domestically, the Network consists of 20 centers, located in 18 cities, in 10 states/territories (including Puerto Rico). There are six international clinical trials sites: five sites in different areas of Brazil, and one in the Bahamas. NICHD also supports laboratory-based pathogenesis-oriented research in the context of clinical trials. The Coordinating Center provides support to clinical trials site investigators with special laboratory expertise for the conduct of specialized pathogenesis-based studies in the context of PACTG protocols. The Coordinating Center provides special support to international sites, such as providing specimen transport through a central Coordinating Center contract with World Courier.
Through the experience of the NICHD Network with directly opening antiretroviral drug treatment trials in sites in Brazil and Bahamas in 1998 and 1999, NICHD identified a need for further training and development to increase Latin American and Caribbean capacity for the conduct of clinical trials, particularly those involving experimental drugs. During 2000, NICHD and the Coordinating Center began the NICHD International Site Development Initiative (NISDI) in Latin America and the Caribbean to address this need. NISDI is designed to provide capacity-building and training to international sites through the conduct of two observational studies: one in HIV-infected pregnant women and their infants, and the other in HIV-exposed, but uninfected infants and HIV-infected infants, children, and adolescents. The goal of this initiative is to train investigators and develop sites that will be able to participate in future international prevention and treatment trials. The Coordinating Center currently subcontracts with 25 sites in six countries participating in the protocols from Mexico, Argentina, Brazil, Bahamas, Jamaica, and Peru. As of July 2006, there were 1,136 pregnant women and 1,522 pediatric patients enrolled into their respective protocols.
NICHD, through the Coordinating Center contract, is conducting a study to evaluate the efficacy of antiretroviral prophylaxis provided only to the infant in situations in which the mother has not received any antiretroviral therapy prior to delivery. This includes women who are first identified as HIV-infected during labor and, therefore, are unable to receive antepartum or intrapartum prophylaxis. This study compares three different types of post-exposure prophylaxis in such infants – standard zidovudine for six weeks to the infant (standard in Brazil and U.S.); a combination of zidovudine with nevirapine; and a triple combination of zidovudine, nevirapine, and nelfinavir. The Coordinating Center is responsible for all aspects of clinical trials management, including protocol and forms design, drug repository and dispensation, regulatory issues, data management, and data analysis. Participating sites include six sites in the U.S., eight sites in Brazil, one site in Argentina, and one site in South Africa in Johannesburg, with a second site about to open in Cape Town.
Collaboration with investigators in southern India on a perinatal HIV-prevention project was initiated in late 2000, entitled "An observational study of the seroprevalence of, and interventions to decrease the risk of maternal to child transmission of HIV in Tamil Nadu, India.” During Stage I of the study, all pregnant women registered in the antenatal clinics were offered the opportunity to participate in an educational session about HIV infection and transmission. Pre- and post-session assessments of knowledge, attitudes, and beliefs were administered to a random sample of women. Voluntary counseling and HIV testing were offered to all women, and the seroprevalence rated was estimated. Enrollment into this part of the protocol took place between December 2003 and December 2004. During Stage II, those women identified as HIV-infected were offered enrollment in a prospective cohort study and offered antiretroviral prophylaxis to prevent mother-to-child transmission (initially zidovudine, then zidovudine plus single-dose nevirapine). Enrollment into this part of the protocol began in early 2004 and the final subject study visits were completed in May 2006. It is anticipated that close-out of sites, analyses, and laboratory testing of stored samples from this study will continue into the new Coordinating Center project period.
As the NICHD international research grant portfolio has increased to include large phase III clinical trials conducted in resource-limited countries, there is an increasing need to ensure that such investigator-initiated trials are conducted ethically, in accordance with Good Clinical Practices, and with attention to human subject safety. The Coordinating Center will conduct site monitoring for selected NICHD grantees conducting large clinical trials to ensure appropriate trial conduct. The Coordinating Center is currently performing site monitoring for the NICHD-funded NEVEREST (Nevirapine Resistance Study) trial evaluating response to therapy in women and children exposed to single-dose nevirapine for prevention of mother-to-child transmission being conducted in South Africa.
Request for Proposals
It is anticipated that one cost-reimbursement, completion type contract will be awarded, for a period of performance of five years, beginning approximately November 1, 2007. RFP-NIH-NICHD – CRMC-2008-01 will be available electronically on or about January 29, 2007, with a closing date tentatively set for April 11, 2007. The RFP may be accessed through the FedBizOpps or through the NICHD website at http://www.nichd.nih.gov/funding/grantcontract/, Research and Development Contracts, Contract Opportunities – Federal Business Opportunities. Offerors are responsible for routinely checking this Web site for any amendments to the solicitation. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted.
Walter A. Knott
NICHD R&D Contracts Management Branch
6100 Executive Boulevard, Room 7A07, MSC 7510
Bethesda, Maryland 20892-7510
Telephone: (301) 435-6924
FAX: (301) 402-3676
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