Phase 1 N=16 Other

Glutathione and Function in HIV Patients

HIV Infection · Erythrocyte Glutathione Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT02348775 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Muscle Glutathione Concentration — 0.5; 2.2 micromol/g.Hb

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: GlyNAC (combination of glycine and n-acetylcysteine) (Dietary_supplement)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Muscle Glutathione Concentration	0.5; 2.2	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

HIV patients:

age 45-65 years

Non-HIV subjects:

age 45-65 years

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02348775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.