Glutathione and Function in HIV Patients

Phase 1

Completed

• Conditions: HIV Infection; Erythrocyte Glutathione Deficiency
• Interventions: Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine)

• Registration Number: NCT02348775
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Detailed data are not as yet available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-28
• Primary Completion: 2018-12
• Study Completion: 2020-08
• Results First Submitted: 2020-11-30
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Results First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

HIV patients:

• age 45-65 years

Non-HIV subjects:

• age 45-65 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GlyNAC	GlyNAC (combination of glycine and n-acetylcysteine)	HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months

Primary Outcome Measures

Name	Time	Method
Muscle Glutathione Concentration	20-weeks	Muscle glutathione concentrations measured by liquid chromatography

Trial Locations

Locations (1)

Baylor Metabolic Research Unit (MRU); 🇺🇸 Houston, Texas, United States