NCT00739258

Brief Summary

It is difficult to detect the intestinal protozoal infections among the HIV-infected persons or travelers diarrhea by using the traditional microscopy or staining methods. The purpose of this study aimed at finding out the appropriate diagnostic methods and the infection rate of the intestinal protozoa, including the Entamoeba, Cryptosporidium and Giardia among the HIV-infected persons by using the antigen detection method and biological method. The investigators also tried to analyze the associated HIV infection status and sexual transmitted diseases (STD) including Gonorrhea, Chlamydial trachomatis, Syphilis, Genital warts and Herpes simplex virus in this study. The study will collect the blood, urine and stool samples from 200 intravenous drug user (IDU) with HIV-infected in the prisons, 400 intravenous drug user (IDU) without HIV infected and 100 intravenous drug user (IDU) with HIV infected receiving methadone maintenance treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 23, 2012

Status Verified

December 1, 2011

Enrollment Period

2.7 years

First QC Date

August 19, 2008

Last Update Submit

January 20, 2012

Conditions

Keywords

HIV-infected personEntamoebaCryptosporidiumGiardiaELISAPCRIDUGonorrheaChlamydial trachomatisSyphilisGenital wartsHerpes simplex virus

Study Arms (3)

HIDU

intravenous drug user (IDU) with HIV infected

IDU

intravenous drug user (IDU) without HIV

MH

persons receiving methadone maintenance treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The samples are obtained from Kaohsiung prison, Kaohsiung women's prison, Pingtung prison and the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

You may qualify if:

  • Clinical diagnosis of HIV
  • Receiving Methadone Maintenance Treatment
  • intravenous drug user (IDU)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

HIV InfectionsGiardiasisGonorrheaSyphilisCondylomata AcuminataHerpes Simplex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesIntestinal Diseases, ParasiticParasitic DiseasesProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialTreponemal InfectionsSpirochaetales InfectionsPapillomavirus InfectionsDNA Virus InfectionsWartsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHerpesviridae Infections

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 23, 2012

Record last verified: 2011-12

Locations