Infection with the human immunodeficiency virus (HIV) results in a progressive loss of immune function, leading to increased susceptibility to malignancies and opportunistic infections. Although there are mixed reports that HIV disease progression can be delayed with antiretroviral therapies, there is currently no cure for this disease. Persons infected with HIV incur a number of physical symptoms, many of which may be amenable to nursing interventions. One of the most prevalent and disabling conditions is progressive wasting. While it was initially considered that nutritional disturbances did not occur until subjects progressed along the HIV infection continuum, more recent reports document that subtle nutritional alterations occur in HIV-infected subjects who are early in their disease course. Although nutritional supplementation in the late stages of HIV illness has been associated with poor outcomes, there is suggestive evidence that nutritional interventions, early in the disease, may be beneficial. The purpose of this pilot study is to evaluate the feasibility of administering nutritional supplements in early HIV infection and to explore the effects of this supplementation on selected measures of nutritional status and HIV disease progression. This study will determine: those factors associated with successful recruitment and retention of a heterogeneous group of HIV-infected persons for a longitudinal nutritional supplementation study; those factors associated with adherence of study subjects to the nutritional supplementation protocol; the relationship between nutritional supplementation and changes in nutritional status measures; and the relationship between nutritional supplementation use and disease progression. Ninety study participants, randomly assigned into either a control group or one of two experimental groups (providing different oral nutritional supplements) will be followed for a twelve month period. Research variables that will be measured at designated intervals include feasibility, nutritional status, and disease progression. If there is preliminary evidence that nutritional supplementation is feasible and effective, a large scale nutritional intervention study will be designed for testing in this population.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR003964-02
Application #
2258003
Study Section
Special Emphasis Panel (SRC)
Program Officer
Sigmon, Hilary D
Project Start
1994-09-30
Project End
1997-07-31
Budget Start
1995-08-01
Budget End
1996-07-31
Support Year
2
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Rush University Medical Center
Department
Type
DUNS #
City
Chicago
State
IL
Country
United States
Zip Code
60612
Keithley, Joyce K; Swanson, Barbara; Zeller, Janice M et al. (2002) Comparison of standard and immune-enhancing oral formulas in asymptomatic HIV-infected persons: a multicenter randomized controlled clinical trial. JPEN J Parenter Enteral Nutr 26:6-14