Trial Outcomes & Findings for Glutathione and Function in HIV Patients (NCT NCT02348775)

NCT ID: NCT02348775

Last Updated: 2021-02-21

Results Overview

Muscle glutathione concentrations measured by liquid chromatography

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: 20-weeks
• Results posted on: 2021-02-21

Participant Flow

Participant milestones

Measure	GlyNAC 8 HIV infected subjects were studied before and after receiving GlyNAC (combination of glycine and n-acetylcysteine) for 12-weeks	Control Arm This comprised of 8 participants not known to have HIV, and did not receive GlyNAC
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glutathione and Function in HIV Patients

Baseline characteristics by cohort

Measure	Cysteine/Glycine n=8 Participants 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	No Supplements n=8 Participants 8 uninfected participants served as controls and were not supplemented	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	54.9 years STANDARD_DEVIATION 4.4 • n=93 Participants	55 years STANDARD_DEVIATION 3.6 • n=4 Participants	55 years STANDARD_DEVIATION 4 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Region of Enrollment United States	8 participants n=93 Participants	8 participants n=4 Participants	16 participants n=27 Participants

PRIMARY outcome

Timeframe: 20-weeks

Muscle glutathione concentrations measured by liquid chromatography

Outcome measures

Measure	GlyNAC n=8 Participants 8 HIV infected subjects were studied before and after receiving oral GlyNAC (glycine plus n-acetylcysteine) for 12-weeks	Control Arm n=8 Participants This comprised of 8 participants not known to have HIV, and did not receive GlyNAC
Muscle Glutathione Concentration	0.5 micromol/g.Hb Standard Deviation 0.2	2.2 micromol/g.Hb Standard Deviation 0.8

Adverse Events

GlyNAC Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

R. V. Sekhar M.D.

Baylor College of Medicine

Phone: 713-798-3908

Email: rsekhar@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place