HIV InfectionsNCT00739258
Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison
An observational study of HIV Infections, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- Type of treatment
- Injection or infusion
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of HIV
- Receiving Methadone Maintenance Treatment
- intravenous drug user (IDU)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison and Set up the Notional Halfway Home in Union Area of Medical Facility
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.
- Conditions
- HIV Infections
- Keywords
- HIV-infected person, Entamoeba, Cryptosporidium, Giardia, ELISA, PCR, IDU, Gonorrhea, Chlamydial trachomatis, Syphilis, Genital warts, Herpes simplex virus
- Medical subject headings
- HIV Infections, Giardiasis, Gonorrhea, Syphilis, Condylomata Acuminata, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIDU | intravenous drug user (IDU) with HIV infected | |
| IDU | intravenous drug user (IDU) without HIV | |
| MH | persons receiving methadone maintenance treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739258
- Sponsor's protocol ID
- KMUH-IRB-970077
- Status last verified
- Dec 2011
- First submitted
- 19 Aug 2008
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison and Set up the Notional Halfway Home in Union Area of Medical Facility
- ClinicalTrials.gov ID
- NCT00739258
- Acronym / sponsor ID
- KMUH-IRB-970077
- Conditions
- HIV Infections
- Keywords
- HIV-infected person, Entamoeba, Cryptosporidium, Giardia, ELISA, PCR, IDU, Gonorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIDU | – | –intravenous drug user (IDU) with HIV infected |
| IDU | – | –intravenous drug user (IDU) without HIV |
| MH | – | –persons receiving methadone maintenance treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of HIV
- Receiving Methadone Maintenance Treatment
- intravenous drug user (IDU)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.