A -- LONG TERM EFFECTS OF POTENT ANTIRETROVIRAL THERAPY ON HIV-INDUCED NERVOUS SYSTEM DISEASE

Notice Date

November 20, 2000

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 6107, MSC 9603, Bethesda, MD, 20892-9603

ZIP Code

20892-9603

Solicitation Number

NIMH-01-AI-0005

Response Due

April 4, 2001

Point of Contact

Alex Navas, Contract Specialist, Phone (301) 443-2696, Fax (301) 443-0501, Email anavas@mail.nih.gov

E-Mail Address

Alex Navas (anavas@mail.nih.gov)

Description

The National Institute of Mental Health (NIMH) intends to issue a solicitation entitled "Long Term Effects Of Potent Antiretroviral Therapy On HIV-Induced Nervous System Disease", as a 100% full and open competitive acquisition under NAICS Code 541710. The purpose of this initiative is to assess the long-term effects of potent ART on HIV-induced disease of the nervous system, focusing on the complete range of neurological, neuropsychological and neurobehavioral outcomes of therapy. The NIMH plans to award one (1), five-year, cost-reimbursement contract to an organization that will function as a coordinating center to conduct and manage this study. The Government estimates that 4-6 sites will be utilized in this study, to assess a total of 400-500 subjects per year, and that 10-20% of these subjects will be followed for a longer period of time (the majority of the patients in this study will be evaluated once). Sites shall be selected through a competition process, after award, with the concurrence of the NIMH. The Contractor/sites shall gather current and on-going data on HIV positive individuals who 1) are currently undergoing antiretroviral treatment for HIV infection; 2) about to start antiretroviral treatment; 3) have undergone ART treatment and stopped; and/or 4) are taking psychotropic or other medications in combination with ART. There is no treatment of HIV positive individuals under this contract; no drug will be administered. The Contractor will be responsible for central coordination including recruiting study sites, protocol development and finalizing the study design, preparing informed consent documents, providing data forms, training, centralized communication, data entry and management, quality control procedures, site monitoring, statistical analysis, report writing and other related activities. Procedures shall be developed for the collection, storage, retrieval and final disposition of patient samples. For subjects that are going to be followed, the Contractor will need to retain and store blood and plasma samples. The Contractor shall propose a centralized laboratory site to receive, process, and store study samples. The study shall address the following broad objectives 1) Assessment of the incidence and prevalence of HIV associated dementia, minor/cognitive motor disorder and neuropsychological impairments including depression and anxiety in HIV infected individuals in all stages of treatment history; 2) Evaluation of viral genotypes in CSF and other body compartments following potent ART; 3) Neuroimaging assessments after potent ART; 4) Assessment of CNS- and peripheral nervous system- related side effects resulting from potent ART such as abnormal lipid metabolism, mitochondrial dysfunction and peripheral neuropathy; 5) Assessment of drug interactions between ART and psychotropic or other medications. Request for Proposal (RFP) No. NIMH-01-AI-0005 will be available on or about December 6, 2000, and the receipt date for proposals will be on or about April 4, 2001. The RFP may be accessed through the NIMH Home Page by using the following instructions: access the home page at http://www.nimh.nih.gov select "Grants and Contracts", select "Contracts", select "NIMH Requests for Proposals (RFP)" and lastly select "NIMH-01-AI-0005". Please note that the RFP for this requirement will include the Statement of Work, Deliverables and Reporting Requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors included in the competitive range will be requested to provide additional documentation to the Contracting Officer. All responsible sources may submit a proposal that will be considered by the NIMH. This advertisement does not commit the government to award a contract. INQUIRIES: For questions or further information, contact: Bruce E. Anderson, Contracting Officer Contracts Management Branch National Institute of Mental Health, NIH Neuroscience Center Bldg., Rm. 6107 (MSC 9603) Bethesda, MD 20892-9603 Telephone: (301) 443-2234 Fax: (301) 443-0501 Email: ba9i@nih.gov

Web Link

Visit this URL for the latest information about this (http://www2.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=P&P=NIMH-01-AI-0005&L=2927)

Record

Loren Data Corp. 20001122/ASOL012.HTM (D-325 SN5070O0)