Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Centers for Disease Control and Prevention.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Miriam Hospital
Minneapolis Medical Research Foundation
Washington University School of Medicine
Denver Infectious Disease Consultants, PLLC
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00146419
First received: September 1, 2005
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

The SUN Study is a Centers for Disease Control and Prevention (CDC)-sponsored multi-site prospective observational cohort study designed to better understand the incidence and etiology of metabolic and other complications related to effective HIV treatment and longer survival. The SUN Study is also providing a platform to evaluate a behavioral intervention designed to reduce HIV transmission through prevention counseling in routine care.


Condition Intervention
HIV Infections
Sexually Transmitted Diseases
Behavioral: Reduction in behaviors capable of sexually transmitting HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study)

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Enrollment: 699
Study Start Date: March 2004
Estimated Study Completion Date: June 2013
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Reduction in behaviors capable of sexually transmitting HIV
    Clinic-level risk reduction counseling
Detailed Description:

Effective antiretroviral therapy has significantly improved and prolonged the lives of HIV-infected persons. However, antiretroviral use has also been associated with a diverse array of "unnatural" metabolic complications and other adverse medical conditions. These problems, together with subsequent longer survival, have increased patients' risk for developing renal, hepatic, cardiovascular, neurological, rheumatologic, and other end-organ diseases, and cancers. Longer survival is also increasing the pool of HIV-infected persons capable of transmitting the virus, which could accelerate the pace of the U.S. epidemic; however, the ability of physicians caring for HIV-infected persons to incorporate prevention into their clinical practices and the effectiveness of this intervention have not been extensively evaluated.

The goals of the Study to Understand the Natural History of HIV and AIDS ("SUN" Study) are:

  • to monitor the incidence of metabolic and other medical complications related to the treatment of HIV infection and attendant prolonged survival,
  • to identify risk factors associated with the development of these metabolic and other medical complications,
  • to monitor the contribution of these complications and other conditions to the morbidity and mortality of HIV infection, and
  • 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.

The SUN Study is designed to enroll and follow for 5 or more years a cohort of up to 1,000 HIV-infected adults at HIV specialty care centers in four U.S. cities: Denver, Minneapolis, Providence, and St. Louis. Data will be gathered through longitudinal real-time chart review, biannual physical examination (e.g., body mass index [BMI], blood pressure), repeated non-invasive imaging (e.g., dual energy x-ray absortiometry [DEXA] scanning, carotid ultrasonography) and regularly scheduled laboratory testing (e.g., serum lipids, pap smears, and urinary microalbumin). Data collection and quality control will be managed by Cerner Corporation. After sufficient enrollment, (circa 200 persons per site) a structured prevention program to reduce HIV transmission will be introduced. The impact of this intervention will be evaluated both subjectively (e.g., self-reported change in behavior on an audio computer-assisted self-interviewing [ACASI] questionnaire) and objectively (e.g., change in sexually transmitted disease [STD] incidence).

Outcomes include determination of the incidence of therapy-related metabolic complications and other adverse conditions associated with longer survival, identification of risk factors for these complications and conditions, and reduction in both reported and objective measures of risky sexual behavior.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected persons receiving care at HIV-specialty clinics

Criteria

Inclusion Criteria:

  • Subject is age 18 years or older.
  • Subject is HIV-infected as confirmed by positive enzyme immunoassay (EIA) and western blot testing, by an HIV viral load >5,000 copies, or by genotyping that confirms infection with HIV.
  • For highly active antiretroviral therapy (HAART)-naïve subjects (i.e. persons with no prior substantial antiretroviral [ARV] exposure):

    • Subject's CD4+ cell count is between 100 and 500 cells/mm³
    • Subject has not ever 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).
  • For HAART-exposed subjects (i.e. persons who have taken or are taking HAART at the time of enrollment):

    • Subject's CD4+ cell count is >100 cells/mm³
    • Subject's previous and/or current treatment with ARVs has consisted only of HAART (of any duration and in any number of regimens) defined as:

      • >3 antiretroviral drugs from at least 2 antiretroviral drug classes (nucleotide reverse transcriptase inhibitors [NRTI], non-nucleoside reverse transcriptase inhibitors [NNRTI], protease inhibitors [PI]); or,
      • >3 NRTIs.
  • Other antiretroviral combinations that in the course of the study are developed and become accepted as equivalent to best available therapy.
  • Subject has received only HAART either as prescribed therapy or in the context of a supervised study.
  • Subject has completed at least two visits within the past year to the clinical facility where the patient is eligible for enrollment.
  • Subject is anticipated to continue receiving care at the clinical facility where she or he is eligible for enrollment for at least 2 years.
  • Subject is able to understand and sign an informed consent.

Exclusion Criteria:

  • Subject is pregnant.
  • Subject is incarcerated. (footnote 1)
  • Within the past 60 days subject has:

    • Had an AIDS-defining opportunistic infection or illness.
    • Received any chemotherapy or immunomodulating therapy (e.g., glucocorticoids, interleukin-2, interferon). (footnote 2)
  • Subject is expected to live less than 2 years.
  • Subject is unable or unwilling to complete any part of the study protocol.
  • 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, etc.
  • Subject is unable or refuses to provide informed written consent due to any physical or psychological incapacity (e.g., persistent vegetative state, mental disability).

Footnotes:

  1. Participants will be temporarily suspended from the study while pregnant or incarcerated after enrollment.
  2. Cases where eligibility by these criteria is unclear or requires special consideration will be referred to the Executive Committee for a final decision.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146419

Locations
United States, Colorado
Denver Infectious Disease Consultants
Denver, Colorado, United States, 80220
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80220
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Park-Nicollet Institute
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02905
United States, Virginia
Cerner Corporation
McLean, Virginia, United States, 22182
Sponsors and Collaborators
The Miriam Hospital
Minneapolis Medical Research Foundation
Washington University School of Medicine
Denver Infectious Disease Consultants, PLLC
Investigators
Principal Investigator: Charles Carpenter, M.D. The Miriam Hospital
Principal Investigator: Keith Henry, M.D. Minneapolis Medical Research Foundation
Principal Investigator: Kristin Mondy, M.D. Washington University School of Medicine
Principal Investigator: John H Hammer, M.D. Denver Infectious Disease Consultants, PLLC
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00146419     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3979, 200-2002-00610, 200-2002-00611, 200-2002-00612, 200-2002-00613
Study First Received: September 1, 2005
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 29, 2014