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

This study is currently recruiting participants.
Verified January 2017 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697540
First Posted: October 2, 2012
Last Update Posted: April 28, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
  Purpose
  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
HIV

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)

Resource links provided by NLM:

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

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

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 Submitted: September 28, 2012
First Posted: October 2, 2012
Last Update Posted: April 28, 2017
Last Verified: January 2017