Glutathione and Function in HIV Patients

February 2, 2021 updated by: Rajagopal V Sekhar, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed data are not as yet available

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor Metabolic Research Unit (MRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GlyNAC
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)
HIV patients will be studied before and after receiving GlyNAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Glutathione Concentration
Time Frame: 20-weeks
Muscle glutathione concentrations measured by liquid chromatography
20-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: R V Sekhar, M.D., Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-34781 HIV-GSH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data from the study will be submitted for publication once analyses are completed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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