Glutathione and Function in HIV Patients

NCTNCT02348775Other idH-34781 HIV-GSH

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glutathione, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase 1
Enrollment: 16 participants (actual)
Sponsor: Baylor College of Medicine · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2014
Primary completion: Dec 2018
Completion: Aug 2020
First posted: 28 Jan 2015 (estimated)
Last update posted: 21 Feb 2021
Conditions: HIV Infection · Erythrocyte Glutathione Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2014201620182020

Ph 1
Glutathione and Function in HIV Patients
NCT02348775
Nov 2014 to Aug 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GlyNAC (combination of glycine and n-acetylcysteine)Dietary supplement

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Muscle Glutathione Concentration
Time frame · 20-weeks
Registry description
Muscle glutathione concentrations measured by liquid chromatography

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 20-weeks

Muscle Glutathione Concentration

Group	Value (micromol/g.Hb)	Spread
GlyNAC	0.5	0.2
Control Arm	2.2	0.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GlyNAC ArmHIV infected subjects will be studied before and after taking GlyNAC for 12-weeks	0 / 8	0 / 8	0 / 8
Control ArmControls will be HIV negative and not receive GlyNAC	0 / 8	0 / 8	0 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 45 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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