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Glutathione and Function in HIV Patients

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ClinicalTrials.gov Identifier: NCT02348775
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rajagopal V Sekhar, Baylor College of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Erythrocyte Glutathione Deficiency Dietary Supplement: Cysteine (as n-acetylcysteine) and glycine Phase 1

Detailed Description:
Detailed data are not as yet available

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Glutathione and Function in HIV Patients
Study Start Date : November 2014
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Cysteine/glycine
Older HIV infected subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 3 months
Dietary Supplement: Cysteine (as n-acetylcysteine) and glycine
HIV patients will be studied before and after receiving cysteine and glycine
Other Name: Cysteine and glycine




Primary Outcome Measures :
  1. Muscle glutathione concentrations measured by liquid chromatography [ Time Frame: 5 months ]


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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

HIV patients:

  • age 45-65 years

Non-HIV subjects:

  • age 45-65 years

Exclusion Criteria:

  1. Hospitalization in the past 3 months
  2. Untreated hypothyroidism or hyperthyroidism
  3. Known diabetes mellitus, hypercortisolemia, coronary artery disease.
  4. Known liver impairment (ALT and AST >2ULN)
  5. Renal impairment (Creatinine>1.4)
  6. Inability to walk
  7. Patients on anticoagulation or antiplatelet therapy.
  8. Patient with triglyceride concentrations >500 mg/dl.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348775


Locations
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United States, Texas
Baylor Metabolic Research Unit (MRU)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: R V Sekhar, M.D. Baylor College of Medicine

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Responsible Party: Rajagopal V Sekhar, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02348775     History of Changes
Other Study ID Numbers: H-34781 HIV-GSH
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from the study will be submitted for publication once analyses are completed

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Acetylcysteine
N-monoacetylcystine
Glycine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Glycine Agents
Neurotransmitter Agents