Glutathione and Its Precursors in HIV-Infected Patients

HIV Infection Clinical Trial

Official title:

The Effect of Substrate Supply on Modulating Plasma GSH Levels in Treated HIV+ Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910442
• Other study ID #: upeclin/HC/FMB-Unesp-24
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2009
• Last updated: May 28, 2009
• Start date: February 2002
• Est. completion date: February 2009

Study information

• Verified date: May 2009
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Dietary Supplement:
• Glutathione precursors
HIV+ patients were assigned to 7 day diets containing either NAC or Gln

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glutathione		7 days	Yes
Secondary	Plasma sulfur amino acids		7 days	Yes