HIV InfectionsNCT00146419
Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study)
An observational study of HIV Infections and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Reduction in behaviors capable of sexually transmitting HIV
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 699 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2004to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected persons receiving care at HIV-specialty clinics
Who may be able to join
- 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):
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Denver Infectious Disease Consultants
Denver, Colorado, 80220
University of Colorado Health Sciences Center
Denver, Colorado, 80220
Cerner Corporation
McLean, Virginia, 22182
Hennepin County Medical Center
Minneapolis, Minnesota, 55404
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Park-Nicollet Institute
Minneapolis, Minnesota, 55416
The Miriam Hospital
Providence, Rhode Island, 02905
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Reduction in behaviors capable of sexually transmitting HIV
- Keywords
- Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction in behaviors capable of sexually transmitting HIVBehavioural
Clinic-level risk reduction counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionAug 2006
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- The Miriam Hospital, Hennepin Healthcare Research Institute, Washington University School of Medicine, Denver Infectious Disease Consultants, PLLC
- Responsible party
- Sponsor
- Investigators
- Charles Carpenter, M.D., Principal investigator, The Miriam HospitalKeith Henry, M.D., Principal investigator, Hennepin Healthcare Research InstituteKristin Mondy, M.D., Principal investigator, Washington University School of MedicineJohn H Hammer, M.D., Principal investigator, Denver Infectious Disease Consultants, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146419
- Sponsor's protocol ID
- CDC-NCHSTP-3979
- Other IDs
- 200-2002-00610, 200-2002-00611, 200-2002-00612, 200-2002-00613
- Status last verified
- Sep 2012
- First submitted
- 1 Sep 2005
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19074775Kojic 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.
PubMed 20966828Steinau 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.
PubMed 20392894Mondy 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.
PubMed 21217185Dao 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.
PubMed 21217186Kyser 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.
PubMed 21293992Overton 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.
PubMed 21480819Mayer 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.
PubMed 22183836Patel 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.
PubMed 22249305Patel 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.
PubMed 22301072Patel 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.
PubMed 22592834Tedaldi 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.
PubMed 23199190Baker 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.
PubMed 24370480Wilson 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.
PubMed 24813472Escota 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.
PubMed 25495766
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study)
- ClinicalTrials.gov ID
- NCT00146419
- Acronym / sponsor ID
- CDC-NCHSTP-3979
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- The Miriam Hospital, Hennepin Healthcare Research Institute, Washington University School of Medicine, Denver Infectious Disease Consultants, PLLC
- Study start
- Mar 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected persons receiving care at HIV-specialty clinics
Key inclusion criteria (15 listed)
- 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):
- For HAART-exposed subjects (i.e. persons who have taken or are taking HAART at the time of enrollment):
- Other antiretroviral combinations that in the course of the study are developed and become accepted as equivalent to best available therapy.
Key exclusion criteria (12 listed)
- Subject is pregnant.
- Subject is incarcerated. (footnote 1)
- Within the past 60 days subject has:
- Subject is expected to live less than 2 years.
- Subject is unable or unwilling to complete any part of the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction in behaviors capable of sexually transmitting HIVClinic-level risk reduction counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Background: PubMed 19074775Vellozzi 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.
- Background: PubMed 20966828Kojic 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.
- Background: PubMed 20392894Steinau 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.
- Background: PubMed 21217185Mondy 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.
- Background: PubMed 21217186Dao 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.
- Background: PubMed 21293992Kyser 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.
- Background: PubMed 21480819Overton 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.
- Background: PubMed 22183836Mayer 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.
- Background: PubMed 22249305Patel 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.
- Background: PubMed 22301072Patel 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.
- Background: PubMed 22592834Patel 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.
- Background: PubMed 23199190Tedaldi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Carpenter, M.D. principal investigator
The Miriam Hospital
Keith Henry, M.D. principal investigator
Hennepin Healthcare Research Institute
Kristin Mondy, M.D. principal investigator
Washington University School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146419, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.