HIV InfectionPhase 1NCT02348775
Glutathione and Function in HIV Patients
A Phase 1 study testing GlyNAC (combination of glycine and n-acetylcysteine) in people with HIV Infection and Erythrocyte Glutathione Deficiency, run by Baylor College of Medicine at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Erythrocyte Glutathione Deficiency
- What is being tested?
- GlyNAC (combination of glycine and n-acetylcysteine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV patients:
- age 45-65 years
- Non-HIV subjects:
- age 45-65 years
Who cannot join
- Hospitalization in the past 3 months
- Untreated hypothyroidism or hyperthyroidism
- Known diabetes mellitus, hypercortisolemia, coronary artery disease.
- Known liver impairment (ALT and AST >2ULN)
- Renal impairment (Creatinine>1.4)
- Inability to walk
- Patients on anticoagulation or antiplatelet therapy.
- Patient with triglyceride concentrations >500 mg/dl.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Metabolic Research Unit (MRU)
Houston, Texas, 77030
About this study
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.
Read the detailed description
Detailed data are not as yet available
- Conditions
- HIV Infection, Erythrocyte Glutathione Deficiency
- Being tested
- GlyNAC (combination of glycine and n-acetylcysteine)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyNAC (combination of glycine and n-acetylcysteine)Dietary supplement
HIV patients will be studied before and after receiving GlyNAC
| Study group | Role | What they receive |
|---|---|---|
| GlyNAC | Experimental | HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months Receives: Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Glutathione Concentration
Muscle glutathione concentrations measured by liquid chromatography
Measured: 20-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajagopal V Sekhar, Baylor College of Medicine
- Investigators
- R V Sekhar, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348775
- Sponsor's protocol ID
- H-34781 HIV-GSH
- Status last verified
- Feb 2021
- First submitted
- 15 Jan 2015
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data from the study will be submitted for publication once analyses are completed
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutathione and Function in HIV Patients
- ClinicalTrials.gov ID
- NCT02348775
- Acronym / sponsor ID
- H-34781 HIV-GSH
- Conditions
- HIV Infection, Erythrocyte Glutathione Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
Detailed data are not as yet available
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlyNAC | Experimental | Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine)HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 45-65 years
- age 45-65 years
Key exclusion criteria (8 listed)
- Hospitalization in the past 3 months
- Untreated hypothyroidism or hyperthyroidism
- Known diabetes mellitus, hypercortisolemia, coronary artery disease.
- Known liver impairment (ALT and AST >2ULN)
- Renal impairment (Creatinine>1.4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlyNAC (combination of glycine and n-acetylcysteine)HIV patients will be studied before and after receiving GlyNAC | Dietary supplement | GlyNAC |
Primary outcome
Muscle Glutathione Concentration
Time frame: 20-weeks
Muscle glutathione concentrations measured by liquid chromatography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data from the study will be submitted for publication once analyses are completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R V Sekhar, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GlyNAC (combination of glycine and n-acetylcysteine) in people with HIV Infection and Erythrocyte Glutathione Deficiency, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Glutathione Concentration (time frame: 20-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.