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

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ClinicalTrials.gov Identifier: NCT01697540
Recruitment Status : Recruiting
First Posted : October 2, 2012
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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Brief 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. 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.

Condition or disease
HIV

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)
Study Start Date : September 2012
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV/AIDS group
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormal liver function: GOT or GPT 5 times over normal upper limit
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01697540


Contacts
Contact: Jih- jin Tsai, MD 886-7-3121101 ext 6638 jijits@cc.kmu.edu.tw

Locations
Taiwan
Tropical medicine center Recruiting
Kaohsiung, Taiwan
Contact: Jih- Jin Tsai, MD    886-7-3121101 ext 6638    jijits@cc.kmu.edu.tw   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01697540     History of Changes
Other Study ID Numbers: KMUHIRB-2012-05-05(I)
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: January 2017