Summaries of Efforts to Evaluate Outcomes of HIV Disease

The HIV/AIDS Program of Cape Cod Hospital was selected as the only beta test site for the testing and development of software designed to improve health care delivered to patients infected with HIV. The software, designed by Ellora Software, Inc. of Devens, MA, helps coordinate all aspects of HIV/AIDS care and the actions of all office personnel involved in the treatment of these patients. In its current form, the program allows narrative notes, details of treatment and lab results, and most importantly, summary reports of individual patient information and compilation of specific details of the entire practice’s database. At the time of completion, the software should be ready for general sales and distribution. Ellora plans to continually enhance its software to incorporate increased efficiency and changes in approach to medical care in this ever changing field.

Contact: Alan M. Sugar, M.D. or Diane Marino, RN at the Infectious Diseases Consulting Service (IDCS), 20 Gleason Street, Hyannis, MA 02601; phone 508-775-0766; fax: 508-778-4753.

The Effect of an Educational Intervention on Treatment Effectiveness Among HIV Positive Clients

This clinical outcomes research project is a three phased study of the effect of an educational intervention on clinical outcomes for clients participating in highly active antiretroviral therapy (HAART) for treatment of HIV infection. Phase I, in process now, will collect descriptive data regarding clinical outcomes in a clinic implementing an innovative educational approach which, it is hypothesized, is characterized as empowerment.

This phase will represent a population study of the approximately 400 HIV positive patients at the clinic. Data regarding treatment, viral load measurement, hospital days, emergency room visits and opportunistic infections will be collected. In addition, quality of life, as measured by the MOS-HIV Health Survey, will be measured. Other measures include client satisfaction and life stress. Finally, a phenomenological component will be used to supplement the researchers’ understanding of the process of empowerment and the lived experience of the educational intervention and antiretroviral regimens.

Subsets for data evaluation will include: (1) those clients who have achieved and maintained a non-detectable viral load on HAART, (2) those clients who have not yet made a decision to begin HAART, (3) those clients who have made a deliberate decision not to begin a HAART, and (4) those clients who began HAART and did not achieve or maintain a non-detectable viral load.

Contact: Sally Neville, R.N., M.S.N., Director HIV Services, Kansas City Free Health Clinic, 2 East 39th St., Kansas City, MO 64111; (816)753-5144; sneville@kc-reach.org.

Effect of WF10 on Survival and Disease Progression in Late-Stage HIV Disease

The primary objective of this study is to compare the effect of WF10 and placebo (physiologic saline) on rates of clinical progression in adult patients with late-stage HIV disease (<50 CD4+ T cells/mm3) receiving stable antiretroviral and standard prophylaxis therapy. In this study, clinical progression is defined as any occurrence of a new AIDS-defining event or mortality. Two hundred forty patients from twenty to thirty trial sites will be randomized in a ratio of 1:1 to receive either WF10 or placebo. Test preparations will be administered by intravenous infusion for four treatment cycles of five consecutive days per cycle, and each cycle separated by a sixteen-day interval. After the initial treatment period of eleven weeks, patients will attend follow-up visits eighteen weeks after the first dose, then at three-month intervals for the first year of the study and at 6-month intervals during the second year of study. Patients will be monitored throughout the study for clinical progression [any occurrence of a new AIDS-defining event or mortality (primary endpoint)] and number, duration, and cause of hospitalizations; quality of life, measured by the MOS-HIV Health Survey; and density of CD38 antigen on CD8+ T cells (secondary endpoints). The study will be terminated and the endpoints will be assessed when the final surviving patient to receive treatment has completed the Week 48 follow-up evaluation. Evaluations after the 48-week time point will be used to assess continued safety and efficacy of WF10. If less than 25% of the total patient population (60 patients) has reached a clinical endpoint, the study may be extended to the Week 96 follow-up evaluation of the last patient receiving treatment.

Contact: Stephan Glenn, Ph.D., RAC, Senior Director of Clinical Development and Regulatory Affairs, OXO Chemie Inc. 601 Gateway Blvd., Suite 450 South San Francisco, CA 94080. (650) 246-2200.

Employment Issues for People with HIV: A Demonstration Project

This demonstration project was initiated to assist people with HIV who wish to enter or reenter the workforce in their efforts to do so. The program uses a comprehensive evaluation, including indices of mental-health functioning, physical well being (for which the SF-36 is used as one indicator), neuropsychological functioning, and vocational interests and skills to help people with HIV to arrive at a vocational rehabilitation plan. Vocational case management is accomplished through a brokered contract with a local municipal job training and career center. Individual program participants are also monitored by program case-management staff, who offer assistance in coordinating community resources in meeting current need.

In addition to its goal of helping people with HIV go to work, the project seeks to identify predictors of successful workforce entry among people with HIV. Project participants are followed for a total of two years at six-month intervals to monitor their workforce-entry efforts, as well as the outcome of their efforts. One evaluation component is the degree to which physical health predicts successful efforts to enter the workforce following an HIV diagnosis and a period of time out of the workforce. The SF-36 and its subscales will be used to predict progress toward workforce entry among project participants (measured by efforts toward getting a job such as obtaining education, job applications, and actual job placement), and as an outcome measure to monitor the health effects of workforce entry.

Contact: David J. Martin, Ph.D., Director, HIV Mental Health Services, Department of Psychiatry, Harbor-UCLA Medical Center, 1000 West Carson Street, Torrance, CA 90509. (310) 222-3196, FAX: (310) 222-3196, email: djmartin@ucla.edu.

The use of Adjuvant Nutrition to Prevent Muscle Wasting in AIDS (Acquired Immunodeficiency Syndrome) Patients.

The overall objective of this research is to test the efficacy of a newly developed nutrient mixture aimed to prevent and revert the wasting that occurs in patients with AIDS. It is anticipated that the results from the proposed study will enable researchers to further refine this tissue-specific nutrient mixture to improve the outcome of the AIDS patient. Hydroxy-methylbutyrate, (HMB), a metabolite of the amino acid leucine, l-Arginine and l-Glutamine have been shown to affect immune function and muscle protein metabolism. Twenty patients with AIDS wasting will be diagnosed by standard CDC criteria and recruited into a 12 week open-labeled study. Subjects will be required to meet with the study coordinator on a weekly basis to: pick up a 7 day supply (14 packets) of a nutritional supplement (each packet contains 7 g of arginine, 7 g glutamine and 1.5 grams of HMB), assess body weight change, and to provide information on health status and emotional well-being (circumplex). Prior to enrollment and after 6 and 12 weeks, body composition, resting energy expenditure, metabolic parameters, and quality of life (MOS-HIV health survey) will be measured. Compliance will be assessed by a self-report form and by blood levels of HMB. The effectiveness of this tissue-specific nutrient mixture will determined by one or more of the following: 1) increased body weight gain, 2) increased lean body mass gain, 3) improved immune status, and/or 4) improved quality of life.

Contact: John A. Rathmacher, Ph.D., Clinical Research Associate, MTI BioTech, Inc., 2625 North Loop Drive, Suite 2150, Ames, IA 50010. (515) 296-9916