HIVNCT01828268
Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection
An observational study of HIV, run by Sichuan Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Recruit 100 HIV-infected individuals from community HIV Clinic and/or Transmitted Disease Hospital of Chengdu
Who may be able to join
- Clinical diagnosis of HIV infection
Who cannot join
- Pregnancy
- Individual who is participating in other trial(s)
Trial locations and contacts
1 site in 1 country.
Bing CAI, Master contact
China1 site, 1 recruiting
- Recruiting
Sichuan Academy of Medical Sciences,Sichuan Provincial Hospital, Metabolomics and Mutidisciplinary Laboratory
Chengdu, Sichuan, 610101
Hua JIANG, PhD, +86-28-88424391, hua.jiang@truamabank.org
Jin PENG, Master
About this study
Official title: Metabolic Fingerprintings and Metabolic Dynamics After HIV Infection:Impact of Metabolic Changes and Anti-Retroviral Therapy, Life Style and Clinical Conditions
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.
Read the 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.
- Conditions
- HIV
- Keywords
- HIV, Metabolomics Fingerprinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV infectors | 100 confirmed HIV-1 infected patients who meet inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyslipidemia
Measured: Dyslipidemia events from admission to discharge(Up to 6 months) )
Secondary outcomes (1)
Lipoatrophy
Measured: Lipoarophy events from admission to discharge (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hua JIANG, PhD, Study chair, 3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary LaboratoryJin PENG, Master, Principal investigator, 3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828268
- Sponsor's protocol ID
- META-HA-001-2013
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2013
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17879926Joly 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.
PubMed 12461419John 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.
PubMed 12792352Zhang 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.
PubMed 19687491Zyromski 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.
PubMed 19451751Friis-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.
PubMed 12819520
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Fingerprintings and Metabolic Dynamics After HIV Infection:Impact of Metabolic Changes and Anti-Retroviral Therapy, Life Style and Clinical Conditions
- ClinicalTrials.gov ID
- NCT01828268
- Acronym / sponsor ID
- META-HA-001-2013
- Conditions
- HIV
- Keywords
- HIV, Metabolomics Fingerprinting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV infectors | – | –100 confirmed HIV-1 infected patients who meet inclusion criteria. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruit 100 HIV-infected individuals from community HIV Clinic and/or Transmitted Disease Hospital of Chengdu
Key inclusion criteria (1 listed)
- Clinical diagnosis of HIV infection
Key exclusion criteria (2 listed)
- Pregnancy
- Individual who is participating in other trial(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dyslipidemia
Time frame: Dyslipidemia events from admission to discharge(Up to 6 months) )
1 secondary outcome
Lipoatrophy
Time frame: Lipoarophy events from admission to discharge (up to 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Background: PubMed 17879926Schackman 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.
- Background: PubMed 12461419Joly 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.
- Background: PubMed 12792352John 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.
- Background: PubMed 19687491Zhang 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.
- Background: PubMed 19451751Zyromski 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.
- Results publication: PubMed 12819520Friis-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.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing CAI, Master contact
Hua JIANG, PhD study chair
3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory
Jin PENG, Master principal investigator
3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Sichuan Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua JIANG, PhD (+86-28-88424391, hua.jiang@traumabank.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyslipidemia (time frame: Dyslipidemia events from admission to discharge(Up to 6 months) )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828268, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.