Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146

B -- DEVELOPMENT OF DIAGNOSTICS FOR SURVEILLANCE OF HIV VARIANTS AND SIMILAR RETROVIRUSES IN CAMEROON SOL 2000-Q-00178 DUE 090800 POC Dale Defilipps, Contract Specialist, Phone (770)488-2637, Fax (770)488-2670, Email DDefilipps@CDC.GOV -- Dale Defilipps, Contract Specialist, Phone (770)488-2637, Fax (770)488-2670, Email DDefilipps@CDC.GOV WEB: Visit this URL for the latest information about this, http://www2.eps.gov/cgi-bin/WebObjects/EPS?ACode=P&ProjID=2000-Q-00178&LocID=2965. E-MAIL: Dale Defilipps, DDefilipps@CDC.GOV. The Centers for Disease Control and Prevention contemplates awarding a Sole Source purchase order to the Care and Health Program (CHP) in Yaounde, Cameroon for obtaining serum, plasma, and viable lymphocytes from persons infected with new HIV variants or closely related retroviruses. Specimen collection will be in accordance with Cameroonian Institutional approval and CDC Institutional Review Board (IRB) approved protocols (IRB approval #1367). For general sampling, retrospective testing and characterization of unlinked specimens, only demographic, clinical, and limited risk information (without personal identifiers) will be recorded. Specifically this information will include age, sex, ethnic group, marital status, socioeconomic status, available risk information, and clinical symptoms. For any prospective collection, consent must be obtained for HIV testing and evaluation, obtaining any extra blood, and any desired follow-up if this consent is not already in place. The vendor must be able to perform each the following tasks: 1) Establish testing sites with various regions and risk groups within Cameroon including the following: patients attending adult and pediatric AIDS clinics patients attending antenatal or STD clinics or Infectious Disease wards, patients attending HIV counseling and testing facilities, and donors at blood banks; 2) Obtain from established sites a VACUTAINER CPT tube blood sample and informed consent from specific subjects as described below: subjects with sero-indeterminate or equivocal positive results on the screening assay, sero-negative subjects with clinical presentation (CDC/WHO stage 2 or above) or low CD4 counts (<200 cells/mm _ in instances where such data is available), and sero-negative subjects with a high risk of infection such as commerical sex workers or subjects whose partners have died of AIDS; 3) Collaborate with Project IRECAM and CDC in screening approximately 2000 specimens with an EIA having a broad sensitivity to HIV. Specimens from persons whose EIA results are above the positive/negative cutoff or within a 20% gray zone will be processed for serum, plasma, and viable lymphocytes; 4) Collaborate with Project IRECAM and CDC in screening approximately 2000 specimens with an EIA having a broad sensitivity to HIV. Specimens from persons whose EIA results are above the positive/negative cutoff or within a 20% gray zone will be processed for serum, plasma, and viable lymphocytes; 5) Collaborate with Project IRECAM and CDC for the selection of individuals with unusual HIV variants and other emerging retroviruses including all individuals with sero-reactivity of greater than three times the negative controls (approximately 5% of samples having absorbencies closest to the cutoff including weak positives and "high" negatives) as well as sero-negative persons with AIDS related clinical symptoms. This also includes viruses from persons with unusual serologic reactivities, such as positive by one screening assay but negative by another or those with strong HIV-1 gag and pol reactivates but weak or missing env bands by Western blots; 6) Ship selected unusual HIV variants and other emerging retroviruses to CDC for laboratory identification and characterization; and 7) At the conclusion of the work, the vendor will prepare and submit to the Project Officer a final report that summarizes the accomplishments of the assignment, methods of work used, recommendations regarding unfinished work, and/or program continuation and recommendations covering the current needs in the fields of activity covered under the terms of this agreement. The final report shall be submitted to the Project Officer 12 months from the date of receipt of the purchase order. The vendor must have knowledge and experience in managing and performing scientific research involving human subjects in the areas specified above. CDC, under 45 CFR 46, is responsible for the highest possible standards in its use of human subjects in research studies and must collaborate only with other scientists and institutions that are required to uphold the same high standards. Therefore, the minimum equirement for a vendor for this work is that the vendor has experience in ensuring that individuals are protected in all public health research activities it conducts. Work is scheduled to commence on or about September 14, 2000 and contiue for 12 months. The Care and Health Program is the only known source that can meet all of the above requirements, hence a Sole Source procurement is contemplated. Responsible sources may submit a response which will be considered by the Agency. Posted 08/07/00 (D-SN483217). (0220)

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