Glutathione and Function in HIV Patients

Baylor College of Medicine

Status and phase: Completed; Phase 1

Conditions: HIV Infection; Erythrocyte Glutathione Deficiency

Treatments: Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02348775

H-34781 HIV-GSH

Details and patient eligibility

About

We have recently reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves (but does not fully normalize) concentrations of red-cell GSH. We also found that when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with an increase in intracellular GSH concentrations. These older HIV patients also had significant increases in muscle strength with improvement of GSH levels.The current proposal in older HIV patients will investigate study if cysteine and glycine supplementation for a duration of 12 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months, GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be measured for a further 2 months to determine the effects of washout.

Full description

Detailed data are not as yet available

Enrollment: 16 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

HIV patients:

• age 45-65 years

Non-HIV subjects:

• age 45-65 years

Exclusion criteria

1. Hospitalization in the past 3 months
2. Untreated hypothyroidism or hyperthyroidism
3. Known diabetes mellitus, hypercortisolemia, coronary artery disease.
4. Known liver impairment (ALT and AST >2ULN)
5. Renal impairment (Creatinine>1.4)
6. Inability to walk
7. Patients on anticoagulation or antiplatelet therapy.
8. Patient with triglyceride concentrations >500 mg/dl.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

GlyNAC

Experimental group

Description:

HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months

Treatment:

Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine)