Follow-on: CNS HIV Anti-Retroviral Therapy Effects Research (CHARTER)

This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. Background. The CNS HIV Antiretroviral Therapy Effects Research (CHARTER) study was awarded in September 2002, under contract N01MH22005, to the University of California at San Diego (UCSD) to examine the presentation and predictors of neurologic complications of HIV in the era of combination antiretroviral treatment (ART). In performance of this contract, UCSD has examined 1,574 participants cross-sectionally, 657 participants longitudinally, and is continuing to follow additional subjects through the contract expiration date in August 2010. Purpose and Objectives. The data collected to date has helped advance the knowledge of the pathophysiology of HIV-Associated Neurocognitive Disorder (HAND), and a continuation of this research is required. The goal of the follow-on research is to continue assessment of subsets of the longitudinal patient cohort studied under this contract. This will provide detailed answers to key follow-up questions based on the preliminary findings. The proposed program may help to identify the biomarkers that annotate disease progression and address key questions relevant to the persistence of HIV-Associated Neurocognitive Disorders (HAND) and inform therapy. Project Requirements. The key issues to be explored include: 1) whether low-level HIV replication in the cerebral spinal fluid is a predictor of HAND; 2) whether HAND will be present in the CHARTER cohort who experienced failure of antiretroviral therapy to control HIV replication in the cerebral spinal fluid, (HAND will be assessed by annual neurocognitive and brain imaging); 3) assessment of the predictors of neurological injury by examining cases that are receiving combination antiretroviral therapy and undergoing cognitive decline or increasing white matter abnormality. Drug resistance profiles, in CSF and Plasma of those cases with neurocognitive decline and increasing white matter abnormality, will be examined to determine the contribution of evolution of viral strains with discordant resistance. evaluation of skin biopsy variables may be required as they are related to key disease and treatment parameters to define the extent to which nerve injury is reversible or irreversible in the context of ART treatment. Other Important Considerations. In order to perform this work, qualified sources shall have: 1) access via informed consent to a cohort of 180 well-characterized, longitudinally studied patients under contract N01MH22005, who have been followed by the University of California at San Diego and at 5 other sites (sub-awards); 2) experience in performing multi-site clinical studies and experience/expertise in neurocognitive and neurological assessments, neuroimaging, virology and genetics. Anticipated Period of Performance. The resulting contract has an anticipated period of performance of 5 years. Capability Statement. Any business or organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (5-10 pages, single-spaced), indicating previous experience and capabilities related to the described work. Capability Statements should describe (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; (e) examples of prior completed Government contracts, references, and other related information (f) any other resources available to support this project. Responses to this Sources Sought Notice are due by February 11, 2010, 4:30 PM local time. Responses can be sent by mail, fax, or E-mail to: Stephanie Powell Contract Specialist, NIDA Neuroscience COAC NIMH R&D Contracts Management Branch 6001 Executive Blvd., Rm. 8154 (MSC 9661) Bethesda, MD 20892 [For commercial overnight services use: Rockville, MD 20852] Voice: 301-443-2696 Fax: 301-443-0501 E-mail: spowel1@mail.nih.gov *NIMH R&D contracts are awarded and administered by the National Institute on Drug Abuse (NIDA), Neuroscience Consolidated Operations Acquisition Center (COAC) Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.