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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2015 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: September 3, 2015

Last verified: September 2015

History of Changes

Purpose

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.

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


Ages Eligible for Study:	Child, Adult, Senior
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

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, see Learn About Clinical Studies.

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


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:	September 3, 2015
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 27, 2016

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