HIVNCT01697540

Management of Highly Active Anti-retroviral Therapy-related Hyperlipidemia Among HIV-infected Patients in Taiwan

An observational study of HIV, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

1. Written informed consent must be obtained before any study specific procedures are undertaken. 2. The process of the experiment (brief describe) The patients must come back for follow during 4 to 12 weeks after starting the new therapy. Read more about this study

Who is it for?: Any age
Conditions the study is for: HIV
How many people: 100 participants
Where: 1 siteTaiwan
Study dates: Sep 2012to 27 Jun 2017
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
No healthy volunteers
Child, Adult, Older adult

Study population: HIV/AIDS group

Who may be able to join

HIV-infected patients who receive HAART therapy but have metabolic side effects.
Age over 20 years old

Who cannot join

Abnormal liver function: GOT or GPT 5 times over normal upper limit

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Tropical medicine center
Kaohsiung City

Other trials in Taiwan

About this study

Official title: Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)

Written informed consent must be obtained before any study specific procedures are undertaken.
The process of the experiment (brief describe) The patients must come back for follow during 4 to 12 weeks after starting the new therapy. The investigators will follow the patients' lipid profile and any side effects and stop the observation till 36 months after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride, cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The patients' chart and all data will be delinked to protect the patients' right and privacy.

Conditions: HIV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201227 Jun 2017

First posted2 Oct 2012 (estimated)
Study startSep 2012
Primary completion27 Jun 2017
Study completion27 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies 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: Case only
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01697540
Sponsor's protocol ID: KMUHIRB-2012-05-05(I)
Status last verified: Jan 2017
First submitted: 28 Sep 2012
Last updated: 9 Aug 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)
ClinicalTrials.gov ID: NCT01697540
Acronym / sponsor ID: KMUHIRB-2012-05-05(I)
Conditions: HIV
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
Study start: Sep 2012
Primary completion: 27 Jun 2017 (actual)
Study completion: 27 Jun 2017 (actual)
First posted: 2 Oct 2012 (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.

Written informed consent must be obtained before any study specific procedures are undertaken.
The process of the experiment (brief describe) The patients must come back for follow during 4 to 12 weeks after starting the new therapy. The investigators will follow the patients' lipid profile and any side effects and stop the observation till 36 months after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride, cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The patients' chart and all data will be delinked to protect the patients' right and privacy.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: HIV/AIDS group

Key inclusion criteria (2 listed)

HIV-infected patients who receive HAART therapy but have metabolic side effects.
Age over 20 years old

Key exclusion criteria (1 listed)

Abnormal liver function: GOT or GPT 5 times over normal upper limit

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 9 Aug 2018.

Related trials for HIV

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HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
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Not yet recruiting
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People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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Recruiting
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Mental Health
RecruitingObservational study
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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, 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 2 inclusion and 1 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 9 Aug 2018. 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?

On the ClinicalTrials.gov record for NCT01697540.

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 9 Aug 2018.