Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection

NCT ID: NCT01828268

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV infectors

100 confirmed HIV-1 infected patients who meet inclusion criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of HIV infection

Exclusion Criteria

* Pregnancy
* Individual who is participating in other trial(s)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sichuan Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hua JIANG, PhD

Role: STUDY_CHAIR

3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory

Jin PENG, Master

Role: PRINCIPAL_INVESTIGATOR

3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory

Locations

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Sichuan Academy of Medical Sciences,Sichuan Provincial Hospital, Metabolomics and Mutidisciplinary Laboratory

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua JIANG, PhD

Role: CONTACT

+86-28-88424391

Bing CAI, Master

Role: CONTACT

+86-28-88424391

Facility Contacts

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Hua JIANG, PhD

Role: primary

+86-28-88424391

References

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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. doi: 10.1086/521933. Epub 2007 Sep 4.

Reference Type BACKGROUND
PMID: 17879926 (View on PubMed)

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. doi: 10.1097/00002030-200212060-00010.

Reference Type BACKGROUND
PMID: 12461419 (View on PubMed)

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. doi: 10.1097/00126334-200305010-00005.

Reference Type BACKGROUND
PMID: 12792352 (View on PubMed)

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. doi: 10.7326/0003-4819-151-4-200908180-00006.

Reference Type BACKGROUND
PMID: 19687491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19451751 (View on PubMed)

Friis-Moller N, Weber R, Reiss P, Thiebaut 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 with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93. doi: 10.1097/01.aids.0000060358.78202.c1.

Reference Type RESULT
PMID: 12819520 (View on PubMed)

Other Identifiers

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META-HA-001-2013

Identifier Type: -

Identifier Source: org_study_id

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