Study Profile:
Micronutrient Metabolism in HIV+ and HIV- Drug Users

October 12, 2006

Tufts University School of Medicine

Micronutrient Metabolism in HIV+ and HIV- Drug Users

Enrolling Subjects

Janet Forrester

2002-2006

The proposed study builds on the existing BIENESTAR study sponsored by NIH/NIDA.

1. Study population will be current participants and new enrollees in the BIENESTAR study.
2. Cross-sectional component (two sets of data): At each visit, we will evaluate current dietary intake , vitamin A absorption, serum albumin, prealbumin and retinal binding protein, liver and renal function, and serum micronutrients. We will also perform tests of fasting glucose, insulin, c-peptide, and TSH to identify participants with diabetes and thyroid abnormalities.
3. Prospective component: The 12 months of follow-up data on each participant constitute the longitudinal component of the study.

1. To determine the prevalence of low to marginal serum levels of the micronutrients vitamin A, ß-carotene, vitamin E, selenium, and zinc among three groups: drug abusers with HIV, drug abusers without HIV, and non drug abusers with HIV.
2. To determine the association between malabsorption and serum micronutrient levels. Malabsorption will be determined by the vitamin A absorption test and the D-xylose test.
3. To determine the association between levels of transport factors and serum micronutrient levels. Transport factors to be examined will be retinal binding protein, prealbumin, albumin, and serum lipoproteins.
4. To determine the role of liver or renal dysfunction in the association between micronutrient transport factors and low to marginal serum micronutrient levels. We will examine subgroups of subjects with and without evidence of liver or renal dysfunction, and measure, within the groups, levels of retinal binding protein, prealbumin, albumin, lipoprotein, and serum micronutrients.

Tufts Medical Center GCRC

250

1. Mother tongue of the subject is Spanish.
2. Subject understands the study, agrees to procedures and follow-up visits, and signs the consent form.
3. Screened for HIV status with an ELISA test.

1. Less than 18 years of age
2. Spanish not first language
3. Cancer present (other than HIV-associated cancers or non-melanoma skin cancer)
4. Diabetes mellitus or thyroid disease present
5. Pregnant at time of recruitment
6. Informed consent not granted

A drug user in this study is defined as anyone who reports having used heroin, cocaine, or other non-prescription drug at least once in the previous 6 months.

Bienestar

Micronutrient Study:

At entry and

12 mos.

Anthropometry:

Height, weight, skinfolds

Bioelectrical Impedance

Hand grip strength

Dietary Intake:

Food frequency questionnaire

24-hour recall + 3-day food record

Clinical Status Questionnaire:

Socio-demographic information

Medical history, medications

Quality of life, depression

Recreational drug use

Energy expenditure:

Indirect calorimetry (REE)

Physical activity recall

Gastrointestinal function:

D-xylose absorption test

Laboratory Tests:

Viral load

CBC, differential, platelets

T-cell subsets

Chemistry

HIV ELISA (Baseline only except in HIV-negative group, in whom it is repeated every 6 months)

Blood Draw:

Vitamins A, E, Carotenes, Selenium, Zinc, Retinol binding protein, prealbumin, lipid profile, a-1 glycoprotein, BUN, serum creatinine, fasting glucose, insulin, c-peptide, thyroid stimulating hormone, prothrombin time, vitamin A absorption

X

Urine Assays:

Urine opiates, cocaine: urinalysis: protein, cells

X

• Screening Questionnaire
• Quality of Life Questionnaire
• Physical Exam
• Food Frequency Questionnaire
• 3-Day Food Record
• Physical Activity Recall