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

NCT00146419 | Completed

• 5 other identifiers: CDC-NCHSTP-3979200-2002-00610200-2002-00611200-2002-00612200-2002-00613
• Study Type: observational
• Target: 699
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

HIV Infections; Sexually Transmitted Diseases

Keywords

Treatment Experienced; Treatment Naive

Interventions

Reduction in behaviors capable of sexually transmitting HIV BEHAVIORAL

Clinic-level risk reduction counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected persons receiving care at HIV-specialty clinics

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Participants will be temporarily suspended from the study while pregnant or incarcerated after enrollment.
• Cases where eligibility by these criteria is unclear or requires special consideration will be referred to the Executive Committee for a final decision.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• The Miriam Hospital: collaborator
• Hennepin Healthcare Research Institute: collaborator
• Washington University School of Medicine: collaborator
• Denver Infectious Disease Consultants, PLLC: collaborator

Study Sites (8)

Denver Infectious Disease Consultants

Denver, Colorado, 80220, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80220, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Park-Nicollet Institute

Minneapolis, Minnesota, 55416, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02905, United States

Location

Cerner Corporation

McLean, Virginia, 22182, United States

Location

Related Publications (16)

• 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.

  PMID: 19074775 BACKGROUND

• 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.

  PMID: 20966828 BACKGROUND

• Steinau M, Swan DC, Onyekwuluje JM, Brooks JT, Vellozzi C, Unger ER, The Sun Study Investigators. 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):2068-2072. doi: 10.1099/vir.0.018663-0. Epub 2010 Apr 14.

  PMID: 20392894 BACKGROUND

• 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.

  PMID: 21217185 BACKGROUND

• 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.

  PMID: 21217186 BACKGROUND

• 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.

  PMID: 21293992 BACKGROUND

• 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.

  PMID: 21480819 BACKGROUND

• 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.

  PMID: 22183836 BACKGROUND

• 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.

  PMID: 22249305 BACKGROUND

• 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.

  PMID: 22301072 BACKGROUND

• 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.

  PMID: 22592834 BACKGROUND

• Tedaldi EM, van den Berg-Wolf M, Richardson J, Patel P, Durham M, Hammer J, Henry K, Metzler S, Onen 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.

  PMID: 23199190 BACKGROUND

• 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.

  PMID: 24370480 BACKGROUND

• Wilson EM, Singh A, Hullsiek KH, Gibson D, Henry WK, Lichtenstein K, Onen 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.

  PMID: 24813472 BACKGROUND

• Escota GV, Patel P, Brooks JT, Bush T, Conley L, Baker J, Kojic EM, Hammer J, Onen 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.

  PMID: 25495766 BACKGROUND

• 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.

  PMID: 26194468 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Carpenter, M.D.

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

• Keith Henry, M.D.

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

• Kristin Mondy, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• John H Hammer, M.D.

  Denver Infectious Disease Consultants, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 7, 2005
• Study Start: March 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: June 1, 2013
• Last Updated: July 30, 2015

Record last verified: 2012-09

Locations

US (8)