Trial record 7 of 35 for:    " March 06, 2013":" April 05, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Metabolomics Fingerprinting and Metabolic Dynamis After HIV Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sichuan Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01828268
First received: April 5, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Fingerprintings and Metabolic Dynamics After HIV Infection:Impact of Metabolic Changes and Anti-Retroviral Therapy, Life Style and Clinical Conditions

Resource links provided by NLM:


Further study details as provided by Sichuan Academy of Medical Sciences:

Primary Outcome Measures:
  • Dyslipidemia [ Time Frame: Dyslipidemia events from admission to discharge(Up to 6 months) ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipoatrophy [ Time Frame: Lipoarophy events from admission to discharge (up to 6 months) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma from peripheral blood


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV infectors
100 confirmed HIV-1 infected patients who meet inclusion criteria.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruit 100 HIV-infected individuals from community HIV Clinic and/or Transmitted Disease Hospital of Chengdu

Criteria

Inclusion Criteria:

  • Clinical diagnosis of HIV infection

Exclusion Criteria:

  • Pregnancy
  • Individual who is participating in other trial(s)
  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: NCT01828268

Contacts
Contact: Hua JIANG, PhD +86-28-88424391 hua.jiang@traumabank.org
Contact: Bing CAI, Master +86-28-88424391

Locations
China, Sichuan
Sichuan Academy of Medical Sciences,Sichuan Provincial Hospital, Metabolomics and Mutidisciplinary Laboratory Recruiting
Chengdu, Sichuan, China, 610101
Contact: Hua JIANG, PhD    +86-28-88424391    hua.jiang@truamabank.org   
Principal Investigator: Jin PENG, Master         
Sponsors and Collaborators
Sichuan Academy of Medical Sciences
Investigators
Study Chair: Hua JIANG, PhD 3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory
Principal Investigator: Jin PENG, Master 3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory
  More Information

Publications:

Responsible Party: Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01828268     History of Changes
Other Study ID Numbers: META-HA-001-2013
Study First Received: April 5, 2013
Last Updated: March 19, 2014
Health Authority: China: Ministry of Health

Keywords provided by Sichuan Academy of Medical Sciences:
HIV
Metabolomics Fingerprinting

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014