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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 September 2012 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01697540
First received: September 28, 2012
Last updated: October 1, 2012
Last verified: September 2012
History of Changes
  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

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: August 2016 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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)
Study First Received: September 28, 2012
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013