SBIR-STTR Award

Reduction of HAART-Induced Side Effects in HIV Patients
Award last edited on: 4/15/02

Sponsored Program
SBIR
Awarding Agency
NIH : NIAT
Total Award Amount
$101,213
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Gerald J Kelliher

Company Information

Kelliher and Associates Ltd

11 Green Hill Lane Suite A
Wynnewood, PA 19096
Location: Single
Congr. District: 05
County: Montgomery

Phase I

Contract Number: 1R43AT000617-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2001
Phase I Amount
$101,213
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.

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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