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Glutathione and Its Precursors in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910442
First Posted: May 29, 2009
Last Update Posted: May 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
UPECLIN HC FM Botucatu Unesp
  Purpose
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.

Condition Intervention Phase
HIV Infection Dietary Supplement: Glutathione precursors Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Plasma glutathione [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Plasma sulfur amino acids [ Time Frame: 7 days ]

Enrollment: 32
Study Start Date: February 2002
Study Completion Date: February 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Glutathione precursors
HIV+ patients were assigned to 7 day diets containing either NAC or Gln
Other Names:
  • Glutamine (L-glutamine)
  • NAC (N-acetyl-L-cysteine)
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.
Dietary Supplement: Glutathione precursors
HIV+ patients were assigned to 7 day diets containing either NAC or Gln
Other Names:
  • Glutamine (L-glutamine)
  • NAC (N-acetyl-L-cysteine)

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910442


Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Roberto C Burini, PhD UNESP Medical School
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberto Carlos Burini, UNESP Faculdade de Medicina de Botucatu
ClinicalTrials.gov Identifier: NCT00910442     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-24
First Submitted: May 27, 2009
First Posted: May 29, 2009
Last Update Posted: May 29, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Acetylcysteine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs