Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection

HIV Clinical Trial

Official title:

Metabolic Fingerprintings and Metabolic Dynamics After HIV Infection:Impact of Metabolic Changes and Anti-Retroviral Therapy, Life Style and Clinical Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01828268
• Other study ID #: META-HA-001-2013
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2013
• Last updated: April 26, 2017
• Start date: March 2013
• Est. completion date: March 2020

Study information

• Verified date: April 2017
• Source: Sichuan Academy of Medical Sciences
• Contact: Hua JIANG, PhD
• Phone: +86-28-88424391
• Email: hua.jiang[@]traumabank.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this plot study is to find out the relationship between metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics methodology.

Description:

Since the clinical application of anti-retroviral therapy (ART) in 1997, the life expectancy of HIV infected patients has been prolonged greatly. However,side effects of ART including metabolic abnormalities have become the main factors influencing patients' quality of life. Among which the abnormal lipid metabolism plays an important role. Meanwhile, metabolic conditions differ from patients applying to different combinations of ART drugs,life style and clinical conditions.

Metabolomics can measure the dynamic metabolic responses of the body to stimuli or modifications. Using nuclear magnetic resonance (NMR) as tools can systematically analyse the process of lipid metabolism. Metabolomics fingerprinting can be defined as the complete complement of small molecule (< 1500 Da) metabolites found in a specific cell, body fluid, organ or organism.

Therefore, the study of the impact of metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions is of importance in enhancing the adherence and improving the clinical outcomes of HIV infected patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of HIV infection

Exclusion Criteria:

• Pregnancy

• Individual who is participating in other trial(s)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences,Sichuan Provincial Hospital, Metabolomics and Mutidisciplinary Laboratory	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (6)

Friis-Møller N, Weber R, Reiss P, Thiébaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group.. Cardiovascular disease risk factors in HIV patients--association — View Citation

John M, McKinnon EJ, James IR, Nolan DA, Herrmann SE, Moore CB, White AJ, Mallal SA. Randomized, controlled, 48-week study of switching stavudine and/or protease inhibitors to combivir/abacavir to prevent or reverse lipoatrophy in HIV-infected patients. J Acquir Immune Defic Syndr. 2003 May 1;33(1):29-33. — View Citation

Joly V, Flandre P, Meiffredy V, Leturque N, Harel M, Aboulker JP, Yeni P. Increased risk of lipoatrophy under stavudine in HIV-1-infected patients: results of a substudy from a comparative trial. AIDS. 2002 Dec 6;16(18):2447-54. — View Citation

Schackman BR, Scott CA, Sax PE, Losina E, Wilkin TJ, McKinnon JE, Swindells S, Weinstein MC, Freedberg KA. Potential risks and benefits of HIV treatment simplification: a simulation model of a proposed clinical trial. Clin Infect Dis. 2007 Oct 15;45(8):1062-70. Epub 2007 Sep 4. — View Citation

Zhang F, Dou Z, Ma Y, Zhao Y, Liu Z, Bulterys M, Chen RY. Five-year outcomes of the China National Free Antiretroviral Treatment Program. Ann Intern Med. 2009 Aug 18;151(4):241-51, W-52. — View Citation

Zyromski NJ, Mathur A, Gowda GA, Murphy C, Swartz-Basile DA, Wade TE, Pitt HA, Raftery D. Nuclear magnetic resonance spectroscopy-based metabolomics of the fatty pancreas: implicating fat in pancreatic pathology. Pancreatology. 2009;9(4):410-9. doi: 10.1159/000199436. Epub 2009 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyslipidemia		Dyslipidemia events from admission to discharge(Up to 6 months) )
Secondary	Lipoatrophy		Lipoarophy events from admission to discharge (up to 6 months)