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Project Concept Review

Project Title: CAM Approaches in the Management of HIV Disease and Its Complications

Council Date: September 5, 2007

Program Officer:
Carol Pontzer
Phone: 301-435-6286
Email: cp253q@nih.gov

Catherine M. Stoney
Phone: 301-402-1272
Email: cs542k@nih.gov

Background

HIV+ individuals on antiretroviral therapy (ART) are significant users of complementary and alternative medicine (CAM). Recent surveys have estimated that between 47% and 74% of HIV+ individuals in the U.S. have used some form of CAM intervention. While some HIV+ people use CAM for specific effects such as to ameliorate fatigue, decrease stress, or diminish lipodystrophy, others are motivated by a desire for a more general improvement in health and an overall sense of well-being. The demographics of U.S. patients on ART who incorporate CAM most often are described as more highly educated, more likely to have been on ART longer, and more likely to experience significant ART-related side effects. Because over half of patients on ART report experiencing symptoms from HIV or their treatment, a greater understanding of the safety and efficacy of CAM therapies among HIV+ patients is necessary.

In the U.S., vitamin and mineral supplementation, often in very high doses, is the most prevalent CAM practice among HIV+ individuals. Increasingly, however, additional CAM therapies are also being used, including meditation, yoga, massage and herbal medicines. Finally, in many developing countries traditional medicine plays a central role in available and accessible care and prevention strategies, although little research has focused on this important aspect of the epidemic. Thus, the rate of CAM use among the HIV+ population to enhance perceived health status and mitigate side effects of ART is high.

Purpose of Proposed Initiative

NCCAM is committed to the study of the role of CAM in HIV prevention and treatment. We have used initiatives in the past to bolster this commitment. The NCCAM Strategic Plan describes the importance of research on HIV-infected populations to our mission,. Mind/body therapies may be particularly beneficial in reducing the stress and symptoms associated with chronic illnesses and their treatment. We explicitly state that we will "Study the effects of various CAM therapies and their mechanisms of action on the state of the nervous, endocrine, and immune systems of individuals experiencing prolonged negative states (e.g., stress, depression, and anxiety)." These conditions are often co-morbid in HIV+ individuals and exacerbated by side effects of ART.

In addition, this initiative derives from the proposed 2009 Trans-NIH Plan for HIV Related Research. Biopsychosocial aspects of HIV disease and treatment will be areas of research focus, and several objectives will deal specifically with CAM and the effects of CAM interventions. Coping mechanisms as well as a reduction in adverse psychological consequences are stressed. One proposed aim is to develop and assess novel interventions to treat HIV disease and minimize the impact of treatment side effects, particularly the cardiovascular and metabolic side effects. Thus, this initiative will meet trans-NIH goals as well as the goals of NCCAM.

Objectives

The proposed initiative is intended to stimulate research on complementary interventions that are frequently used in the management of HIV disease and the complications associated with ART. This is an important scientific focus area given the widespread use of CAM by HIV+ individuals to ameliorate symptoms of disease and side effects of conventional treatment. CAM interventions anticipated to be of greatest relevance in HIV are dietary supplementation and mind/body interventions. Examples of potential topics include but are not limited to:

Proposed Funding Mechanisms

This initiative will use the RFA to solicit R01 applications. It is anticipated that 4 R01s will be funded per year for 3 years (FY 09-FY11). This would entail approximately $2 M in FY 09.