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NCT02348775 · ClinicalTrials.gov registry record · Phase 1
Glutathione and Function in HIV Patients
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02348775: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT02348775 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348775, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
Muscle glutathione concentrations measured by liquid chromatography
Interventions
- DIETARY_SUPPLEMENT GlyNAC (combination of glycine and n-acetylcysteine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-11 |
| Est. Completion | 2020-08 |
| Phase | Phase 1 |
What the finished NCT02348775 record still lists
NCT02348775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which GlyNAC (combination of glycine and n-acetylcysteine) is the first listed.
NCT02348775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02348775 about?
NCT02348775 is a clinical study titled "Glutathione and Function in HIV Patients". 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 norma...
What is the current status of trial NCT02348775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-11. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02348775?
The interventions under investigation include: GlyNAC (combination of glycine and n-acetylcysteine) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02348775?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02348775's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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