A Phase 1 interventional study of GlyNAC (combination of glycine and n-acetylcysteine) in HIV Infection and Erythrocyte Glutathione Deficiency, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Other
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.
Detailed data are not as yet available
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 16 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 111 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
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HIV patients:
Non-HIV subjects:
Exclusion Criteria:
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
Muscle Glutathione Concentration
Muscle glutathione concentrations measured by liquid chromatography
Time frame: 20-weeks
| Milestone | GlyNAC | Control Arm |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
Muscle glutathione concentrations measured by liquid chromatography
| micromol/g.Hb | GlyNAC | Control Arm |
|---|---|---|
| Muscle Glutathione Concentration | 0.5 ± 0.2 | 2.2 ± 0.8 |
Collected over 20 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GlyNAC Arm | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Control Arm | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Cysteine/Glycine | No Supplements | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 16 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cysteine/Glycine | No Supplements | Total |
|---|---|---|---|
| Mean | 54.9 ± 4.4 | 55 ± 3.6 | 55 ± 4 |
| Sex: Female, Male(Participants) | Cysteine/Glycine | No Supplements | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 6 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Cysteine/Glycine | No Supplements | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 8 | 16 |
| Region of Enrollment(participants) | Cysteine/Glycine | No Supplements | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
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Plan to share: Yes — Data from the study will be submitted for publication once analyses are completed
The record gives a start of Nov 2014, a primary completion of Dec 2018 and a completion of Aug 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2021, 2 years 2 months after primary completion.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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