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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146419
First Posted: September 7, 2005
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Centers for Disease Control and Prevention
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

Publications:
Vellozzi C, Brooks JT, Bush TJ, Conley LJ, Henry K, Carpenter CC, Overton ET, Hammer J, Wood K, Holmberg SD; SUN Study Investigators. The study to understand the natural history of HIV and AIDS in the era of effective therapy (SUN Study). Am J Epidemiol. 2009 Mar 1;169(5):642-52. doi: 10.1093/aje/kwn361. Epub 2008 Dec 13.
Kojic EM, Cu-Uvin S, Conley L, Bush T, Onyekwuluje J, Swan DC, Unger ER, Henry K, Hammer JH, Overton ET, Darragh TM, Palefsky JM, Vellozzi C, Patel P, Brooks JT. Human papillomavirus infection and cytologic abnormalities of the anus and cervix among HIV-infected women in the study to understand the natural history of HIV/AIDS in the era of effective therapy (the SUN study). Sex Transm Dis. 2011 Apr;38(4):253-9. doi: 10.1097/OLQ.0b013e3181f70253.
Steinau M, Swan DC, Onyekwuluje JM, Brooks JT, Vellozzi C, Unger ER; SUN Study Investigators3. Differences and changes in human papillomavirus type 16 variant status in human immunodeficiency virus-positive adults are not uncommon. J Gen Virol. 2010 Aug;91(Pt 8):2068-72. doi: 10.1099/vir.0.018663-0. Epub 2010 Apr 14.
Mondy KE, Gottdiener J, Overton ET, Henry K, Bush T, Conley L, Hammer J, Carpenter CC, Kojic E, Patel P, Brooks JT; SUN Study Investigators. High Prevalence of Echocardiographic Abnormalities among HIV-infected Persons in the Era of Highly Active Antiretroviral Therapy. Clin Infect Dis. 2011 Feb 1;52(3):378-86. doi: 10.1093/cid/ciq066. Epub 2010 Dec 9.
Dao CN, Patel P, Overton ET, Rhame F, Pals SL, Johnson C, Bush T, Brooks JT; Study to Understand the Natural History of HIV and AIDS in the Era of Effective Therapy (SUN) Investigators. Low vitamin D among HIV-infected adults: prevalence of and risk factors for low vitamin D Levels in a cohort of HIV-infected adults and comparison to prevalence among adults in the US general population. Clin Infect Dis. 2011 Feb 1;52(3):396-405. doi: 10.1093/cid/ciq158.
Kyser M, Buchacz K, Bush TJ, Conley LJ, Hammer J, Henry K, Kojic EM, Milam J, Overton ET, Wood KC, Brooks JT. Factors associated with non-adherence to antiretroviral therapy in the SUN study. AIDS Care. 2011 May;23(5):601-11. doi: 10.1080/09540121.2010.525603.
Overton ET, Patel P, Mondy K, Bush T, Conley L, Rhame F, Kojic EM, Hammer J, Henry K, Brooks JT; Sun Study Investigators. Cystatin C and baseline renal function among HIV-infected persons in the SUN Study. AIDS Res Hum Retroviruses. 2012 Feb;28(2):148-55. doi: 10.1089/AID.2011.0018. Epub 2011 May 25.
Mayer KH, Bush T, Henry K, Overton ET, Hammer J, Richardson J, Wood K, Conley L, Papp J, Caliendo AM, Patel P, Brooks JT; SUN Investigators. Ongoing sexually transmitted disease acquisition and risk-taking behavior among US HIV-infected patients in primary care: implications for prevention interventions. Sex Transm Dis. 2012 Jan;39(1):1-7. doi: 10.1097/OLQ.0b013e31823b1922.
Patel P, Bush T, Mayer KH, Desai S, Henry K, Overton ET, Conley L, Hammer J, Brooks JT; SUN Study Investigators. Prevalence and risk factors associated with herpes simplex virus-2 infection in a contemporary cohort of HIV-infected persons in the United States. Sex Transm Dis. 2012 Feb;39(2):154-60. doi: 10.1097/OLQ.0b013e318239d7fd.
Patel P, Bush T, Overton T, Baker J, Hammer J, Kojic E, Conley L, Henry K, Brooks JT; SUN Study Investigators. Effect of abacavir on acute changes in biomarkers associated with cardiovascular dysfunction. Antivir Ther. 2012;17(4):755-61. doi: 10.3851/IMP2020. Epub 2011 Dec 16.
Patel P, Bush T, Mayer K, Milam J, Richardson J, Hammer J, Henry K, Overton T, Conley L, Marks G, Brooks JT; SUN Study Investigators. Routine brief risk-reduction counseling with biannual STD testing reduces STD incidence among HIV-infected men who have sex with men in care. Sex Transm Dis. 2012 Jun;39(6):470-4. doi: 10.1097/OLQ.0b013e31824b3110.
Tedaldi EM, van den Berg-Wolf M, Richardson J, Patel P, Durham M, Hammer J, Henry K, Metzler S, Önen N, Conley L, Wood K, Brooks JT, Buchacz K; SUN Study Investigators. Sadness in the SUN: using computerized screening to analyze correlates of depression and adherence in HIV-infected adults in the United States. AIDS Patient Care STDS. 2012 Dec;26(12):718-29. doi: 10.1089/apc.2012.0132.
Baker JV, Hullsiek KH, Singh A, Wilson E, Henry K, Lichtenstein K, Onen N, Kojic E, Patel P, Brooks JT, Hodis HN, Budoff M, Sereti I; CDC SUN Study Investigators. Immunologic predictors of coronary artery calcium progression in a contemporary HIV cohort. AIDS. 2014 Mar 27;28(6):831-40. doi: 10.1097/QAD.0000000000000145.
Wilson EM, Singh A, Hullsiek KH, Gibson D, Henry WK, Lichtenstein K, Önen NF, Kojic E, Patel P, Brooks JT, Sereti I, Baker JV; Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study) Investigators. Monocyte-activation phenotypes are associated with biomarkers of inflammation and coagulation in chronic HIV infection. J Infect Dis. 2014 Nov 1;210(9):1396-406. doi: 10.1093/infdis/jiu275. Epub 2014 May 9.
Escota GV, Patel P, Brooks JT, Bush T, Conley L, Baker J, Kojic EM, Hammer J, Önen NF; SUN Study Investigators. Short communication: The Veterans Aging Cohort Study Index is an effective tool to assess baseline frailty status in a contemporary cohort of HIV-infected persons. AIDS Res Hum Retroviruses. 2015 Mar;31(3):313-7. doi: 10.1089/AID.2014.0225. Epub 2015 Jan 20.
Battalora L, Buchacz K, Armon C, Overton ET, Hammer J, Patel P, Chmiel JS, Wood K, Bush TJ, Spear JR, Brooks JT, Young B; HIV Outpatient Study (HOPS) and SUN Study Investigators. Low bone mineral density and risk of incident fracture in HIV-infected adults. Antivir Ther. 2016;21(1):45-54. doi: 10.3851/IMP2979. Epub 2015 Jul 21.

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
First Submitted: September 1, 2005
First Posted: September 7, 2005
Last Update Posted: July 30, 2015
Last Verified: September 2012

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

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


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