This trial is active, not recruiting.

Conditions hiv infection, erythrocyte glutathione deficiency
Treatment cysteine (as n-acetylcysteine) and glycine
Phase phase 1
Sponsor Baylor College of Medicine
Start date November 2014
End date December 2016
Trial size 16 participants
Trial identifier NCT02348775, H-34781 HIV-GSH


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Older HIV infected subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 3 months
cysteine (as n-acetylcysteine) and glycine Cysteine and glycine
HIV patients will be studied before and after receiving cysteine and glycine

Primary Outcomes

Muscle glutathione concentrations measured by liquid chromatography
time frame: 5 months

Eligibility Criteria

Male or female participants from 45 years up to 65 years old.

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.

Additional Information

Official title Glutathione and Function in HIV Patients
Principal investigator R V Sekhar, M.D.
Description Detailed data are not as yet available
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.