Trial Outcomes & Findings for N-acetylcysteine to Reduce Oxidative Stress and Improve Endothelial Function in HIV-infected Older Adults (NCT NCT01962961)
NCT ID: NCT01962961
Last Updated: 2016-02-08
Results Overview
Measure of oxidative stress
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
PharmaNAC 1800 mg
PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
PharmaNAC 3600 mg
PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
|
Placebo
Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N-acetylcysteine to Reduce Oxidative Stress and Improve Endothelial Function in HIV-infected Older Adults
Baseline characteristics by cohort
| Measure |
PharmaNAC 1800 mg
n=9 Participants
PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
PharmaNAC 3600 mg
n=8 Participants
PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
|
Placebo
n=7 Participants
Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=99 Participants
|
53 years
n=107 Participants
|
54 years
n=206 Participants
|
53 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.
Measure of oxidative stress
Outcome measures
| Measure |
PharmaNAC 1800 mg
n=9 Participants
PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
PharmaNAC 3600 mg
n=7 Participants
PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
|
Placebo
n=6 Participants
Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
|---|---|---|---|
|
Change in Circulating Malondialdehyde Levels
|
0.17 micromolar
Standard Deviation 1.74
|
-0.12 micromolar
Standard Deviation .054
|
-0.00 micromolar
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.
Oxidative stress measure
Outcome measures
| Measure |
PharmaNAC 1800 mg
n=9 Participants
PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
PharmaNAC 3600 mg
n=7 Participants
PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
|
Placebo
n=6 Participants
Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
|---|---|---|---|
|
Change in Circulating F2-isoprostane Levels
|
-12.78 pg/mL
Standard Deviation 26.39
|
-4.84 pg/mL
Standard Deviation 28.85
|
11.76 pg/mL
Standard Deviation 28.76
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.
Measure of endothelial function
Outcome measures
| Measure |
PharmaNAC 1800 mg
n=7 Participants
PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
PharmaNAC 3600 mg
n=9 Participants
PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
|
Placebo
n=6 Participants
Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
|---|---|---|---|
|
Change in Flow-mediated Dilation (FMD) of the Brachial Artery
|
0.51 Percentage of vessel diameter
Standard Deviation 2.00
|
-.046 Percentage of vessel diameter
Standard Deviation 2.18
|
-1.15 Percentage of vessel diameter
Standard Deviation 2.56
|
Adverse Events
PharmaNAC 1800 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PharmaNAC 3600 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PharmaNAC 1800 mg
n=9 participants at risk
PharmaNAC 900 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
PharmaNAC 3600 mg
n=8 participants at risk
PharmaNAC 1800 mg orally twice daily for 8 weeks
PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).
|
Placebo
n=7 participants at risk
Matching placebo pills given twice daily for 8 weeks
Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
22.2%
2/9 • Number of events 2 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 8 weeks
|
25.0%
2/8 • Number of events 2 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Infections and infestations
Fever
|
0.00%
0/9 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Increased HIV viral load
|
55.6%
5/9 • Number of events 5 • 8 weeks
|
25.0%
2/8 • Number of events 2 • 8 weeks
|
42.9%
3/7 • Number of events 3 • 8 weeks
|
|
Infections and infestations
Urinary infection
|
0.00%
0/9 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/9 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
42.9%
3/7 • Number of events 3 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion/sinusitis
|
0.00%
0/9 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
28.6%
2/7 • Number of events 2 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Swelling
|
11.1%
1/9 • Number of events 1 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place