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OpenTrials
Completed

NCT Number: NCT00859677

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

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

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Key information

Conditions

HIV Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Staphylococcal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center San Diego, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-AND-

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Infectious Diseases Clinical Research Program
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: MRSA-2

Important dates

Study start
2009
Primary completion
2010
Study completion
2016
First posted
Mar 11, 2009
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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