Glutathione and Its Precursors in HIV-Infected Patients
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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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients |
- Plasma glutathione [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Plasma sulfur amino acids [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| 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:
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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:
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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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided by UPECLIN HC FM Botucatu Unesp
Additional 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 |
| Study First Received: | May 27, 2009 |
| Last Updated: | May 28, 2009 |
| Health Authority: | Brazil: Ministry of Health |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Acetylcysteine N-monoacetylcystine |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 23, 2013