Glutathione and Function in HIV Patients

NCT02348775 | Completed Phase 1 Results

• 1 other identifier: H-34781 HIV-GSH
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Erythrocyte Glutathione Deficiency

Outcome Measures

Primary Outcomes (1)

• Muscle Glutathione Concentration

  Muscle glutathione concentrations measured by liquid chromatography

  20-weeks

Study Arms (1)

GlyNAC

EXPERIMENTAL

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

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

Interventions

GlyNAC (combination of glycine and n-acetylcysteine) DIETARY_SUPPLEMENT

HIV patients will be studied before and after receiving GlyNAC

GlyNAC

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV patients:
• age 45-65 years
• Non-HIV subjects:
• age 45-65 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor Metabolic Research Unit (MRU)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: R. V. Sekhar M.D.
• Organization: Baylor College of Medicine

rsekhar@bcm.edu

713-798-3908

Study Officials

• R V Sekhar, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 28, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)