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Glutathione and Its Precursors in HIV-Infected Patients

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Glutathione precursors
Sponsored by
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patient Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Plasma glutathione

    Secondary Outcome Measures

    Plasma sulfur amino acids

    Full Information

    First Posted
    May 27, 2009
    Last Updated
    May 28, 2009
    Sponsor
    UPECLIN HC FM Botucatu Unesp
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00910442
    Brief Title
    Glutathione and Its Precursors in HIV-Infected Patients
    Official Title
    The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UPECLIN HC FM Botucatu Unesp
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Introduction: Among the 4 sulphur-containing amino acids (SAA), only Met and Cys are incorporated into proteins, but Hcy and Tau are related to oxidative stress and glutathione (GSH), the major intracellular hydro-soluble anti-oxidant agent. HIV+ patients present low levels of antioxidant nutrients, including GSH and its precursors. Objective: To investigate the responses of the SAA pathway to dietary supplements of Gln and Cys together with Met-overloading in HIV+ patients comparatively to healthy controls. Methods: Twelve HIV+ (6 males and 6 females, 25-36 yrs old) patients under HAART (one HIV protease inhibitor in combination with two nucleoside analogs) for at least one year and 20 (10M and 10F, 23-28 yrs old) healthy controls were randomly assigned to 7-day diets containing either NAC (N-acetylcysteine, 1g/d) or Gln (20g/d), with a 7-day washout period with their usual diet (UD). Blood samples were drawn after overnight fast before and after (2h and 4h) ingesting the Met (100 mg/kg) overload (Met-OL) with determination of the area under the curve (AUC). HPLC plasma analysis of SAA (Met, Hcy, Cys and Tau), GSH and GSSG and Ser, Gly, Glu and Gln was carried out at moments before (MO) and after 7-day diets (M1). Additionally, at baseline, both groups were assessed for anthropometry (BMI, kg/m2; body fat %) and plasma biochemistry (creatinine, urea, γ-glutamyl transpeptidase, glucose, triglycerides, cholesterol, uric acid, albumin, folic acid and vitamin B12).The HIV+ group (G2) was also characterized by the viral load, CD4+ and CD8+ lymphocytes counts. Statistical comparisons were undertaken among diets between groups with p = 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Glutathione precursors
    Other Intervention Name(s)
    Glutamine (L-glutamine), NAC (N-acetyl-L-cysteine)
    Intervention Description
    HIV+ patients were assigned to 7 day diets containing either NAC or Gln
    Primary Outcome Measure Information:
    Title
    Plasma glutathione
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Plasma sulfur amino acids
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roberto C Burini, PhD
    Organizational Affiliation
    UNESP Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29392418
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    22261571
    Citation
    Borges-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.
    Results Reference
    derived

    Learn more about this trial

    Glutathione and Its Precursors in HIV-Infected Patients

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