An observational study in HIV Infections and Sexually Transmitted Diseases, sponsored by Centers for Disease Control and Prevention. Completed at 8 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-30.
Sponsored by Centers for Disease Control and Prevention · Observational
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.
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:
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.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 699 is above the median of 513 across 74 observational studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
HIV-infected persons receiving care at HIV-specialty clinics
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):
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:
Exclusion Criteria:
Within the past 60 days subject has:
Footnotes:
Clinic-level risk reduction counseling
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases→
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