Glutathione and Its Precursors in HIV-Infected Patients
The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine (Met)-overloading in HIV+ patients comparatively to healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2002
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 27, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedMay 29, 2009
May 1, 2009
5 years
May 27, 2009
May 28, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma glutathione
7 days
Secondary Outcomes (1)
Plasma sulfur amino acids
7 days
Study Arms (2)
Patient Group
EXPERIMENTALDietary supplement:N-acetylcysteine 1g/day and Glutamine 20g/day for 7 consecutive days. The dietary supplements were intermediated by 7 days of washout with usual diet.
Control Group
ACTIVE COMPARATORHealthy HIV negative subjects submitted to the same dietary supplement than experimental group: N-acetylcysteine 1g/day and Glutamine 20g/day for 7 consecutive days. The dietary supplements were intermediated by 7 days of washout with usual diet.
Interventions
HIV+ patients were assigned to 7 day diets containing either NAC or Gln
Eligibility Criteria
You may qualify if:
- HIV infection
- antiretroviral therapy for at least one year
You may not qualify if:
- presence of any renal or liver failure
- ingestion of either vitamins B or GSH precursors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Burini RC, Borges-Santos MD, Moreto F, Yu YM. Comparative effects of acute-methionine loading on the plasma sulfur-amino acids in NAC-supplemented HIV+ patients and healthy controls. Amino Acids. 2018 May;50(5):569-576. doi: 10.1007/s00726-018-2538-2. Epub 2018 Feb 1.
PMID: 29392418DERIVEDBorges-Santos MD, Moreto F, Pereira PC, Ming-Yu Y, Burini RC. Plasma glutathione of HIV(+) patients responded positively and differently to dietary supplementation with cysteine or glutamine. Nutrition. 2012 Jul;28(7-8):753-6. doi: 10.1016/j.nut.2011.10.014. Epub 2012 Jan 20.
PMID: 22261571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto C Burini, PhD
UNESP Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 27, 2009
First Posted
May 29, 2009
Study Start
February 1, 2002
Primary Completion
February 1, 2007
Study Completion
February 1, 2009
Last Updated
May 29, 2009
Record last verified: 2009-05