Role of HIV on Glutathione Synthesis and Oxidative Stress

Completed · Phase 1

Conditions studied: HIV Infection, Erythrocyte Glutathione Deficiency

In brief

HIV infection is associated the development of increased oxidative stress and deficiency of glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of GSH. Importantly, short-term dietary supplementation with the simple GSH precursor amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations, corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with HIV, and will test a simple, inexpensive and rational therapy based on protein supplementation to improve GSH synthesis and concentrations and lower markers of oxidative stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry; (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in these subjects.

Key facts

Study ID

NCT01355198

Run by

Baylor College of Medicine

People needed

10

Starts

2010-08-01

Expected to finish

2011-09-01

Last updated by the study team

2013-02-07

Who can join

Age: 21 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• (1) HIV infected patients with GSH deficiency

You may not qualify if…

• renal impairment (serum Creatinine above 1.5mg/dL), liver impairment (ALT and AST > 2x upper limit of normal)
• any hormonal disorders such as hypothyroidism, hypercortisolemia, hypogonadism, or diabetes mellitus on pharmacotherapy
• evidence of infections other than HIV in the preceding 3 months
• subjects with plasma triglyceride concentrations of ≥ 500mg/dL on triglyceride lowering therapy
• BMI < 20
• established heart disease
• Co-existing viral hepatitis B and C

Where it is running

• Baylor GCRC — Houston, Texas, United States

Full record on ClinicalTrials.gov

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