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Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630162
First Posted: March 6, 2008
Last Update Posted: February 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
  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 biologic 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

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

Resource links provided by NLM:


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

Estimated Enrollment: 400
Study Start Date: March 2007
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 biologic 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of HIV-1 Disease
  • Clinical diagnosis of Intestinal protozoal infections
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630162


Locations
Taiwan
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaoshiung, Taiwan
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

ClinicalTrials.gov Identifier: NCT00630162     History of Changes
Other Study ID Numbers: QM094008
First Submitted: February 26, 2008
First Posted: March 6, 2008
Last Update Posted: February 3, 2009
Last Verified: May 2008

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Protozoan Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Parasitic Diseases


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