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Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

This study is currently recruiting participants.
Verified by Kaohsiung Medical University Chung-Ho Memorial Hospital, March 2007

Sponsored by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT00630162
  Purpose

In this two-year study, we will target two high risk groups, including MSM of HIV-infected and those of non-HIV-infected. We will avail the serodiagnosis to detect the potential amebic carriers in both groups; and use microscopy to detect protozoas other than amebiasis. Meanwhile we will also survey the patients' status of sexual transmitted diseases (STD). For the amebic carriers, we will apply specific antigen and molecular bilolgic method to follow up the duration of the persistence of fecal amebas. We try to clarify the dynamic change of amebic carriage.


Condition Intervention
HIV Infections
Protozoan Infections
Genetic: amoeba

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other
Official Title:   Survey of Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Estimated Enrollment:   400
Study Start Date:   March 2007
Estimated Study Completion Date:   July 2008

Detailed Description:

HIV-infected persons who are men having sex with men (MSM) are prone to acquire invasive amebiasis. It would cast great threat for public health if the pathogens are spread by way of human to human transmission and food contamination.

From 2000 to 2004, we assessed the seroprevalence of Entamoeba histolytica infection using indirect hemagglutination antibody (IHA) assay among 667 HIV-infected persons (group 1), 1311 asymptomatic HIV-uninfected persons seeking anonymous HIV testing (group 2), 616 HIV-uninfected controls with gastrointestinal symptoms (diarrhea and/or liver abscess) seeking medical care (group 3), and 2500 healthy controls undergoing health check-up (group 4). An IHA titer greater than 128 was detected in 7.1% of group 1, 2.5% of group 2, 1.8% of group 3, and 0.1% of group 4 (p<0.0001). The highest seroprevalence (11.2%) was noted among HIV-infected persons who were MSM aged 30 to 39 years. Compared with persons with gastrointestinal symptoms, the adjusted odds ratio for having high IHA titers among HIV-infected persons was 3.206 (95% confidence interval, 1.433, 7.176) (p=0.005). These findings demonstrate that HIV-infected persons, especially MSM aged 30 to 39 years, are at significantly higher risk of E. histolytica infection.

In this two-year study, we will target two high risk groups, including MSM of HIV-infected and those of non-HIV-infected. We will avail the serodiagnosis to detect the potential amebic carriers in both groups; and use microscopy to detect protozoas other than amebiasis. Meanwhile we will also survey the patients' status of sexual transmitted diseases (STD). For the amebic carriers, we will apply specific antigen and molecular bilolgic method to follow up the duration of the persistence of fecal amebas. We try to clarify the dynamic change of amebic carriage.

We anticipate this study could outline the epidemiology and risk factors of protozoal infections and STD in MSM cohorts. We also hope to reduce the the infection rate (protozoa and HIV) and disease rate (STD) through the repetitively effective health education and consultation during the conduct of this study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Clinical diagnosis of HIV-1 Disease
  • Clinical diagnosis of Intestinal protozoal infections
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630162

Contacts
Contact: Jih-Jin Tsai, MD     886-7-3121101 Ext. 5677     jijits@cc.kmu.edu.tw    

Locations
Taiwan
Kaoshing Medical University Chung-Ho Memorial Hospital     Recruiting
      Kaoshiung, Taiwan
      Contact: Jih-Jin Tsai, MD     886-7-3121101 ext 5677     jijits@cc.kmu.edu.tw    

Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators
Study Director:     Jih-Jin Tsai, MD     Chung-Ho Memorial Hospital,Kaohsiung Medical University    
  More Information


Study ID Numbers:   QM094008
First Received:   February 26, 2008
Last Updated:   March 5, 2008
ClinicalTrials.gov Identifier:   NCT00630162
Health Authority:   Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
protozoa  
Amoeba  

Study placed in the following topic categories:
Virus Diseases
Protozoan Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Parasitic Diseases
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 10, 2008




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