Abstract
Purpose: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung and Blood Institute (NHLBI) seek applications to develop and test strategies for treating the metabolic complications associated with anti-retroviral drug therapy in patients with HIV infection. In recent years, the advent of highly active anti-retroviral therapy (HAART) has dramatically improved the survival of patients infected with HIV. Despite the benefits of the new anti-retroviral therapies, HAART has been associated with a variety of metabolic complications - including dyslipidemia, insulin resistance and abnormal distribution of body fat (lipodystrophy) - all of which are major risk factors for the development of other serious diseases, such as diabetes and cardiovascular disease. Of particular concern for many patients has been the problem of lipodystrophy, characterized by increased deposition of fat in the abdomen and trunk, and/or loss of fat in the face and extremities. Distress over these often disfiguring changes has caused some patients to stop taking anti-viral medications. This RFA solicits clinical studies to 1) test the efficacy, in patients infected with HIV, of agents currently approved for the treatment of dyslipidemia, insulin resistance or diabetes, and osteoporosis, and 2) develop and test novel treatment approaches to HAART-associated metabolic changes, including lipodystrophy.
Term/Amount: For fiscal year 2002, the NIDDK intends to commit approximately $2 million and the NHLBI intends to commit approximately $500,000 to fund 4-10 grants in response to this RFA. An applicant may request a project period of up to 5 years for R01s and up to two years for R21s. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK and the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit.
Contact: The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.pdf is to be used in applying for these grants. This version of PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email:
Deadline: Letter of Intent Receipt Date: February 21, 2002. Application Receipt Date: March 21, 2002.