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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GlyNAC | Experimental | HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlyNAC (combination of glycine and n-acetylcysteine) | Dietary Supplement | HIV patients will be studied before and after receiving GlyNAC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Glutathione Concentration | Muscle glutathione concentrations measured by liquid chromatography | 20-weeks |
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Inclusion Criteria:
HIV patients:
Non-HIV subjects:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R V Sekhar, M.D. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Metabolic Research Unit (MRU) | Houston | Texas | 77030 | United States |
Data from the study will be submitted for publication once analyses are completed
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| ID | Title | Description |
|---|---|---|
| FG000 | GlyNAC | 8 HIV infected subjects were studied before and after receiving GlyNAC (combination of glycine and n-acetylcysteine) for 12-weeks |
| FG001 | Control Arm | This comprised of 8 participants not known to have HIV, and did not receive GlyNAC |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cysteine/Glycine | 8 HIV infected subjects were studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 3 months, and compared to 8 uninfected controls Cysteine (as n-acetylcysteine) and glycine: Only HIV patients were studied before and after receiving cysteine and glycine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Muscle Glutathione Concentration | Muscle glutathione concentrations measured by liquid chromatography | Posted | Mean | Standard Deviation | micromol/g.Hb | 20-weeks |
|
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GlyNAC Arm | HIV infected subjects will be studied before and after taking GlyNAC for 12-weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. V. Sekhar M.D. | Baylor College of Medicine | 713-798-3908 | rsekhar@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Feb 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2021 | Feb 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| No Supplements |
8 uninfected participants served as controls and were not supplemented |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control Arm | Controls will be HIV negative and not receive GlyNAC | 0 | 8 | 0 | 8 | 0 | 8 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |