Phase 1
Completed N=16
Glutathione and Function in HIV Patients
HIV · Erythrocyte Glutathione Deficiency
Source: ClinicalTrials.gov NCT02348775 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Muscle Glutathione Concentration — 0.5; 2.2 micromol/g.Hb
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscle Glutathione Concentration |
0.5; 2.2 | — |
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.
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. Informational only — not medical advice.