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N-acetylcysteine to Reduce Oxidative Stress and Improve Endothelial Function in HIV-infected Older Adults

This study has been completed.
Sponsor:
Collaborator:
BioAdvantex Pharma
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University
ClinicalTrials.gov Identifier:
NCT01962961
First received: October 11, 2013
Last updated: January 11, 2016
Last verified: December 2015
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
Endothelial Dysfunction
Oxidative Stress
Interventions: Dietary Supplement: PharmaNAC (N-acetylcysteine)
Dietary Supplement: Matching placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    PharmaNAC 1800 mg     PharmaNAC 3600 mg     Placebo  
STARTED     9     8     7  
COMPLETED     9     7     6  
NOT COMPLETED     0     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    PharmaNAC 1800 mg     PharmaNAC 3600 mg     Placebo     Total  
Number of Participants  
[units: participants]
  9     8     7     24  
Age  
[units: years]
Mean (Full Range)
  52  
  (50 to 61)  
  53  
  (51 to 57)  
  54  
  (50 to 57)  
  53  
  (50 to 61)  
Gender  
[units: participants]
       
Female     1     0     3     4  
Male     8     8     4     20  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     1     0     1     2  
Not Hispanic or Latino     8     8     6     22  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     6     3     4     13  
White     1     5     3     9  
More than one race     1     0     0     1  
Unknown or Not Reported     1     0     0     1  



  Outcome Measures
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1.  Primary:   Change in Circulating Malondialdehyde Levels   [ Time Frame: Baseline and 8 weeks ]

2.  Primary:   Change in Circulating F2-isoprostane Levels   [ Time Frame: Baseline and 8 weeks ]

3.  Primary:   Change in Flow-mediated Dilation (FMD) of the Brachial Artery   [ Time Frame: Baseline and 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Samir K. Gupta
Organization: Indiana University School of Medicine
phone: 317-274-7926
e-mail: sgupta1@iu.edu



Responsible Party: Samir K Gupta, MD, MS, Indiana University
ClinicalTrials.gov Identifier: NCT01962961     History of Changes
Other Study ID Numbers: IU SRI 1306011647
Study First Received: October 11, 2013
Results First Received: November 4, 2015
Last Updated: January 11, 2016
Health Authority: United States: Institutional Review Board