Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection (MRSA-2)

This study has suspended participant recruitment.
(Enrollment was stopped due to staffing issues.)
Infectious Diseases Clinical Research Program
Information provided by (Responsible Party):
Brian Agan, Uniformed Services University of the Health Sciences Identifier:
First received: March 10, 2009
Last updated: December 4, 2014
Last verified: December 2014

The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the pathogenesis of MRSA infections.

HIV Infections
Staphylococcal Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection

Resource links provided by NLM:

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • To compare distribution of Th17 cells and their functionality, in the peripheral blood of HIV-positive patients who are infected with MRSA with that of HIV-positive patients who are not colonized or infected with Staphylococcus aureus. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare distribution of Th17 cells in the peripheral blood of groups of HIV-positive and HIV-negative participants who are colonized with MRSA as well as those who have a MRSA infection. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Compare Th17 cells in peripheral blood of HIV-negative participants with MRSA infection with that of HIV-negative subjects not colonized of infected with Staph aureus. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Collect information on factors that may play a role in development of MRSA colonization/infection. Includes demographic, hygienic, exercise-related, and sexual factors which may contribute to MRSA. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Skin biopsy will be obtained.

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
HIV-positive and MRSA negative
HIV-positive and MRSA infected (skin/soft tissue)
HIV-positive and MRSA colonized
HIV-negative and MRSA negative
HIV-negative and MRSA infected (skin/soft tissue)
HIV-negative and MRSA colonized


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-positive and negative patients with a recent screen for MRSA colonization or a history of MRSA infection will be asked to participate. Participants will be recruited by providers within the infectious disease clinics at the sites. In addtion, MRSA isolates will be monitored at the central laboratory and providers of patients with MRSA will be notified and asked to notify their patients of the opportunity to participate in this study.


All participant inclusion criteria:

  • Greater or equal to 18 years of age
  • Willingness to undergo blood draw. Skin biopsy will be requested, but is optional


HIV-positive and MRSA-negative Group:

  • Documented positive HIV test result
  • Negative colonization swabs for S. aureus within 14 days of enrollment
  • No evidence of skin/soft tissue infection

HIV-positive and MRSA-Colonization Group:

  • Documented positive HIV test result
  • History of of colonization with MRSA w/in 14 days of study enrollment

HIV-positive and MRSA Infection Group:

  • Documented positive HIV test result
  • Skin/soft tissue infection with a positive wound culture showing MRSA within 7 days of enrollment
  • MRSA infection is not associated with an intravenous catheter or other nosocomial procedure

HIV Negative groups:

  • Same criteria used for the HIV-negative groups as listed above.
  • No history of HIV infection.
  • Willing to undergo an HIV blood test, which must have a negative result.

Exclusion Criteria:

  • Women with positive urine pregnancy test within 7 days of study enrollment
  • Women who are within 6 months of being postpartum or who are currently breastfeeding
  • Subjects unable or unwilling to complete questionnaires and blood draw.
  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 identifier: NCT00859677

United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
  More Information

No publications provided

Responsible Party: Brian Agan, Deputy Science Director, IDCRP, Uniformed Services University of the Health Sciences Identifier: NCT00859677     History of Changes
Other Study ID Numbers: IDCRP -023
Study First Received: March 10, 2009
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:
Methicillin-resistant Staphylococcus aureus (MRSA)
HIV and Staphylococcus aureus infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
Disease Susceptibility
HIV Infections
Staphylococcal Infections
Bacterial Infections
Disease Attributes
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 26, 2015