Contracts Management Branch, NICHD, National Institutes of Health, Executive Building, Suite 7A07, 6100 Executive Blvd MSC 7510, Bethesda, Maryland 20892-7510

A -- SUBCONTRACTING OPPORTUNITY FOR STUDYING PERINATAL TRANSMISSION N OF HIV-1 SOL N01-HD-3-3162A DUE 122096 POC Contact Mrs. Carol Nesel, 301/738-8337 The National Institute of Child Health and Human Development (NICHD) announces subcontracting opportunities under an ongoing contract with Westat, Inc. Through this contract NICHD sponsors a network of clinical centers which participate in clinical trials of therapies to prevent mother to child transmission of HIV infection and to treat pediatric HIV disease. NICHD plans to further assess the critical factors responsible for perinatal transmission of HIV-1 by conducting the following two studies: (1) The influence of ovulatory phase on the detection of HIV-1 in the vaginocervical secretions from HIV seropositive women; and (2) Herpes simplex virus (HSV) shedding and HIV plasma viral load in HIV-seropositive/ HSV-seropositive women and HIV-seropositive/HSV-seronegative women. These studies will involve obtaining data on immunologic and virologic factors associated with HIV-1 shedding in the female genital tract. It is the intent of NICHD and Westat to award subcontracts to qualified organizations to perform this research. Organizations interested in conducting study (1) should submit five copies of a statement of capabilities which must include the following: (a) evidence of an existing longitudinal co-hort of HIV-1 seropositive women (b) demonstrated ability to perform intensive substudies requiring weekly interviews and gynecologic examinations for eight weeks (c) demonstrated ability to collect, process, and ship cervicovaginal secretions according to current state of the art procedures, (d) a description of staff qualifications (include CVs of the proposed Principal Investigator (PI), description of HIV-related and non-HIV-related research experience (types and number of studies including drug trials, natural history studies, etc., total patient enrollment per study); and e) a description of the physical facilities where work is to be conducted. Organizations interested in conducting study (2) should submit five copies of a statement of capabilities which must include the following: (a) evidence of an existing longitudinal co-hort of HIV-1 seropositive women (b) demonstrated ability to perform intensive substudies requiring daily oral and genital swab specimens and thrice weekly blood draws for four weeks (c) a description of staff qualifications (include CVs of the proposed Principal Investigator (PI), description of HIV-related and non-HIV-related research experience (types and number of studies including drug trials, natural history studies, etc., total patient enrollment per study); and d) a description of the physical facilities where work is to be conducted. Capability statements (limited to 10 pages exclusive of CVs) for performing one or both of the studies above should be submitted to Ms. Carol Nesel, Associate Director, Westat, Inc., 1650 Research Boulevard, Rockville, MD 20850. The deadline for submission is 2:00pm EST December 20, 1996. (0337)

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