CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
GlyNAC (combination of glycine and n-acetylcysteine)dietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02348775
NCT02348775Phase 1Completed

Glutathione and Function in HIV Patients

Baylor College of Medicine·interventional·Posted Jan 28, 2015·Updated Feb 21, 2021

In Brief

A Phase 1 clinical trial evaluating GlyNAC (combination of glycine and n-acetylcysteine) for HIV Infection and Erythrocyte Glutathione Deficiency. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2018
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.4 years ago

Interventions

GlyNAC (combination of glycine and n-acetylcysteine)dietary

HIV patients will be studied before and after receiving GlyNAC