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Trial · Interventional

CompletedPhase 2Registry data

Glutathione and Its Precursors in HIV-Infected Patients

NCTNCT00910442 (opens ClinicalTrials.gov in a new tab)Other idupeclin/HC/FMB-Unesp-24
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Overview

Status
Completed
Phase
Phase 2
Enrollment
32 participants (actual)
Sponsor
UPECLIN HC FM Botucatu Unesp · Other
Design
Randomized · Triple masking
Countries
Not stated
Start
Feb 2002
Primary completion
Feb 2007
Completion
Feb 2009
First posted
29 May 2009 (estimated)
Last update posted
29 May 2009 (estimated)
Conditions
HIV Infection

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022004200620082010
  1. Ph 2

    Glutathione and Its Precursors in HIV-Infected Patients

    NCT00910442

    Feb 2002 to Feb 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Glutathione precursorsDietary supplement

Arms2

  • Experimental

    Patient Group

    Dietary 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.

  • Active comparator

    Control Group

    Healthy 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Plasma glutathione

    Time frame · 7 days

Secondary outcomes(1)

  1. Plasma sulfur amino acids

    Time frame · 7 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedBurini 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 29392418
  • DerivedBorges-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 22261571

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * HIV infection * antiretroviral therapy for at least one year Exclusion Criteria: * presence of any renal or liver failure * ingestion of either vitamins B or GSH precursors

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