Glutathione and Function in HIV Patients

HIV Infection Clinical Trial

Official title:

Glutathione and Function in HIV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348775
• Other study ID #: H-34781 HIV-GSH
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: August 2020

Study information

• Verified date: February 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Detailed data are not as yet available

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythrocyte Glutathione Deficiency
• HIV Infection
• HIV Infections

Intervention

Dietary Supplement:
• GlyNAC (combination of glycine and n-acetylcysteine)
HIV patients will be studied before and after receiving GlyNAC

Locations

Country	Name	City	State
United States	Baylor Metabolic Research Unit (MRU)	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Glutathione Concentration	Muscle glutathione concentrations measured by liquid chromatography	20-weeks