We intend to provide highly specialized clinical consultation services to providers and patients in order to increase the health and well being of people infected with HIV/AIDS. The Highly Active Anti Retroviral Therapy (HAART) can cause severe side effects, often making people feel worse than from the disease and leading to significant changes in body composition and metabolism This often leads to a change in therapy or a """"""""drug holiday"""""""" where medications are stopped for a short period. In this project we will further develop protocols, incorporating a multidisciplinary team of a nutritionist, pharmacist and exercise physiologist, to reduce the side effects of antiviral therapies. Our protocols will seek to markedly reduce the lipodystrophy found in 83% of patients on protease inhibitors, the hyperlipidemia found in 74% and the hyperglycemia in 16%. Using a two cohort design with 15 patients in treatment cohort and 25 in the control, we will incorporate dietary and nutrient supplementation combined with pharmacy drug adherence strategies and a program of resistance exercise for 12 weeks to evaluate the effects of these strategies on biochemical values, physical assessment, side effect incidence and quality of life. The control group will continue to receive the community standard of care throughout the 12 weeks. The results of our study will provide caregivers and patients with specific strategies to reduce the side effects from antiviral therapies and increase the time that patients can continue on effective virus suppressing therapies.

Proposed Commercial Applications

HAART dramatically increases the life expectancy for the nearly half million Americans infected with HIV, but side effects are very common. Through protocols involving diet, pharmacy counseling and exercise we aim to dramatically reduce the side effects of HAART.
We aim to develop teams in the cities with the highest prevalence of HIV infection. These teams will expand their reach through Internet assisted tools to deliver care to a large number of patients.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AT000617-01
Application #
6337710
Study Section
Special Emphasis Panel (ZRG1-AARR-8 (10))
Program Officer
Kagan, Jonathan M
Project Start
2001-08-27
Project End
2002-02-28
Budget Start
2001-08-27
Budget End
2002-02-28
Support Year
1
Fiscal Year
2001
Total Cost
$101,213
Indirect Cost
Name
Kelliher and Associates
Department
Type
DUNS #
City
Dresher
State
PA
Country
United States
Zip Code
19025