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Study Profile:
Study to Understand the Natural History of HIV and AIDS (The SUN Study)

Revised:

July 7, 2003

Study Site:

The Miriam Hospital/Brown University School of Medicine (participating in a multisite CDC study with Denver, Minneapolis, and St. Louis)

Study Name:

Study to Understand the Natural History of HIV and AIDS (The SUN Study)

Study Status:

Baseline Enrollment Complete

Principal Investigator:

Charles Carpenter, MD with
Susan Cu-Uvin, MD
Kenneth Mayer, MD

Years of Funding:

2002-2007 (though it is anticipated that the study will continue beyond that time)

Study Aims:

The purpose of the project is to:

  1. To monitor the incidence of metabolic and other medical complications related to the treatment of HIV infection and attendant prolonged survival, including, but not limited to cardiovascular, neurological, hormonal, bone, hepatic, and renal diseases;
  2. To identify risk factors associated with the development of these metabolic and other medical complications;
  3. To monitor the contribution of these complications and other conditions to the morbidity and mortality of HIV infection; and,
  4. To evaluate the efficacy of a structured program of prevention activities, which are integrated into the routine medical care of HIV patients to reduce HIV transmission

Study or Clinic Location

The Miriam Hospital (as well as sites in Denver, Minneapolis, and St. Louis)

# of Participants:

Goal:

800

Enrolled:

770

Inclusion Criteria:

  1. Subject is age 18 years or older.
  2. Subject is HIV-infected as confirmed by positive ELISA and Western blot testing.
  3. For HAART-naïve subjects (i.e. persons with no prior substantial ARV exposure):
    1. Subject’s CD4+ cell count is between 100 and 500 cells/mm³
    2. Subject has not previously received more than 30 days consecutive or non-consecutive treatment with any ARVs, regardless of reason (e.g., pharmacokinetic study, post-exposure prophylaxis, prevention of vertical transmission in pregnancy).
  4. For HAART-exposed subjects (i.e. persons who have taken or are taking HAART at the time of enrollment):
    1. Subject’s CD4+ cell count is >100 cells/mm³.
    2. Subject’s previous and/or current treatment with ARVs has consisted only of HAART, defined as a regimen of
      1. >3 antiretroviral drugs from at least 2 antiretroviral drug classes (NRTI, NNRTI, PI)
      2. >3 NRTIs
    3. Subject has received only HAART and only since July 1, 1996.
  5. Subject has completed at least two visits within the past year to the clinical facility where the patient is eligible for enrollment.
  6. Subject is anticipated to continue receiving care at the clinical facility where she or he is eligible for enrollment for at least 2 years.
  7. Subject is able to understand and sign an informed consent.

Exclusion Criteria:

  1. Subject is pregnant.
  2. Subject is incarcerated
  3. Within the past 60 days subject has:
    1. Had an AIDS-defining opportunistic infection or illness.
    2. Received any chemotherapy or immunomodulating therapy (e.g., glucocorticoids, interleukin-2, interferon) .
  4. Subject is expected to live less than 2 years.
  5. Subject is unable or unwilling to complete any part of the study protocol.
  6. Subject is considered by the principal investigator to be ineligible for enrollment for any other reason, including but not limited to remote geographic location, experience in prior research studies, inconsistency as a historian, etcetera.
  7. Subject is unable or refuses to provide informed written consent due to any physical or psychological incapacity (e.g., persistent vegetative state, mental disability).

Definition of Drug Use

Participant Characteristics:

% Female:

40% (Providence)

% HIV+

100%

% DU (IDU or non-IDU)

Study Domains:

  • Physical examination: anthropometry, blood pressure, EKG
  • Laboratory examination: Blood, urine, cytological and HPV specimen collection, trichomonas vaginalis specimen collection, other non-study related specimens of interest to investigators
  • Non-invasive imaging examination: coronary artery calcium determination, carotid artery ultrasound, cardiac ultrasound, DEXA scanning, abdominal computer tomography
  • Questionnaire: medical and family history, medication use, smoking, alcohol and non-prescription drug use, physical activity, quality of life, menses and birth control, sexual activity, sexually transmitted diseases, and clinical care received at institutions other than study site
  • Neurocognitive examination: ImPACT instrument
  • Medical record review: to gather information relevant to study’s objectives, including records related to the evaluation, diagnosis and treatment of HIV/AIDS, CVD, renal disease, hepatic disease, bone disease, endocrine diseases, neurological disease, cancer, infectious diseases, psychiatric disease

Data collection instruments:

See examination schedule below

EXAMINATION SCHEDULE

 

Initial Visit

Every 6 months

Every 12 months

Cost paid by SUN Study

Physical Examination

Weight

X

X

Height

X

X

Circumferences:

X

X

  waist

X

X

  hip

X

X

Blood pressure

X

X

Electrocardiogram

X

X

Blood Samples

Glucose, fasting

X

X

Insulin, fasting

X

X

Creatinine

X

X

Potassium

X

X

Complete blood count:

X

X

  White blood cell count (WBC)

X

X

    neutrophil percentage

X

X

    band form percentage

X

X

    lymphocyte percentage

X

X

     monocyte percentage

X

X

    eosinophil percentage

X

X

  Red cell count (RBC)

X

X

  Hematocrit (HCT)

X

X

  Hemoglobin (HGB)

X

X

  Platelet count (PLT)

X

X

 

Liver function tests:

   AST/SGOT

X

X

   ALT/SGPT

X

X

  Bilirubin, direct

X

X

   Bilirubin, indirect

X

X

 

Prothrombin time (PT)

X

X

Partial thromboplastin time (PTT)

X

X

 

Immunological parameters:

  CD4+ cell, absolute cell count

X

X

  CD4+ cell, percentage

X

X

  CD8+ cell, absolute cell count

X

X

  CD8+ cell, percentage

X

X

  HLA profile

X

X

 

Lipids:

Cholesterol, total, fasting

X

X

LDL cholesterol, fasting

X

X

HDL cholesterol, fasting

X

X

Triglycerides, fasting

X

X

 

Virology:

  HIV viral load

X

X

  Hepatitis A total Ig

X

X

  Hepatitis B surface antigen

X

X

  Hepatitis B surface antibody

X

X

  Hepatitis B core antibody

X

X

  Hepatitis C IgG

X

X

  HSV 1 and 2 IgG

X

X

X

  CMV IgG

X

X

X

  EBV IgG

X

X

X

 

Endocrine:

  Testosterone, total

X

X

  Testosterone, free

X

X

  Thyroid stimulating hormone (TSH)

X

X

  Leptin, fasting

X

X

X

  Adiponectin, fasting

X

X

X

 

Other:

   VDRL

 

Urine Samples

Urine dipstick:

   Glucose

X

X

   Protein

X

X

   Leukoesterase

X

X

  hCG (as needed to evaluate for pregnancy)

X

X

Urinalysis:

X

X

Creatinine, spot

X

X

Microalbumin, spot

X

X

Urine N. gonorrhea (gonorrhea) screen

X

X

X

Urine C. trachomatis (chlamydia)screen

X

X

X

T. vaginalis screen
men: urine
women: self-administered vaginal swab

X

X

X

 

Other Clinical Samples

Anal HPV screen

X

X

X

Women only:

 Cervical Pap smear

X

X

 Cervical HPV screen

X

X

X

 

Imaging

Coronary artery calcification by computer tomography

X

X

X

Carotid ultrasound

X

X

X

Abdominal CT "fat slice"

X

X

X

DEXA scan, whole body scan

X

X

X

DEXA scan, femoral head (hip) bone density

X

X

X

DEXA scan, lumbar spine bone density

X

X

X

Echocardiogram

X

X

X

 

Questionnaire

X

X

 

Neurocognitive Examination

X

X

 

 

 

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