HIVPhase 1/2NCT01962961
N-acetylcysteine to Reduce Oxidative Stress and Improve Endothelial Function in HIV-infected Older Adults
A Phase 1/2 study testing PharmaNAC (N-acetylcysteine) in people with HIV and Endothelial Dysfunction, run by Indiana University at 1 site in United States.
Trial summary
The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces oxidative stress and improves vascular function in HIV-infected older adults already on HIV treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV, Endothelial Dysfunction, Oxidative Stress
- What is being tested?
- PharmaNAC (N-acetylcysteine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, documented by (1) any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or (2) by two detectable HIV-1 antigens, or (3) two detectable plasma HIV-1 RNA viral loads.
- Age equal to or greater than 50 years.
- Receipt of antiretroviral therapy of any kind for at least 6 months prior to screening.
- HIV-1 RNA level < 75 copies/mL at screening.
- For women who are still of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study. Acceptable forms of birth control include condoms (with or without a gel that can kill sperm), a diaphragm or cervical cap (with or without a gel that can kill sperm), an intrauterine device (IUD), or hormonal-based birth control ("the pill").
Who cannot join
- Inability to complete written, informed consent.
- Incarceration at the time of any study visit.
- Known allergy or intolerance to n-acetylcysteine.
- Use of n-acetylcysteine within 180 days of screening.
- Diagnosed vascular disease (history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
- History of congestive heart failure even if currently compensated.
Show all 28Show fewer
- History of portal hypertension or hepatic cirrhosis (either clinically diagnosed or histologically diagnosed).
- Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases).
- Known or suspected malignancy requiring systemic treatment within six months of screening.
- History of ADA-defined diabetes mellitus (115)
- History of migraine headaches.
- History of Raynaud's phenomenon.
- History of cardiac arrhythmias or cardiomyopathy.
- Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment.
- Asthma or COPD requiring daily use of beta-2-agonist therapy (e.g. albuterol)
- History of carotid bruits.
- Creatinine clearance < 50 mL/min (using the Cockcroft-Gault equation) using a serum creatinine level measured at screening.
- Hemoglobin < 9.0 g/dL at screening.
- Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) > 3 times ULN at screening.
- Total bilirubin > 2.5 times ULN at screening; if the participant is receiving atazanavir, then s/he would be excluded if total bilirubin is > 3.5 times ULN at screening.
- Therapy for serious medical illnesses within 14 days prior to screening.
- Pregnancy or breastfeeding during the course of the study.
- Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening.
- Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at screening.
- Previous receipt of stavudine or didanosine for more than 7 cumulative days.
- Receipt of daily Vitamin C or Vitamin E supplements at screening.
- Alcohol intake more than the equivalent of one 8 oz. of wine daily for the 7 days prior to screening.
- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health University Hospital, Indiana Clinical Research Center
Indianapolis, Indiana, 46202
About this study
Official title: A Randomized, Placebo-Controlled Pilot Trial Assessing Two Doses of N-Acetylcysteine on Changes in Oxidative Stress and Endothelial Function in HIV-infected Older Adults Receiving Stable Antiretroviral Therapy
The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces oxidative stress and improves vascular function in HIV-infected older adults already on HIV treatment.
Read the detailed description
The primary objective of this study is to compare 8-week changes in circulating levels of malondialdehyde (MDA), circulating levels of F2-isoprostanes, and flow-mediated dilation (FMD) of the brachial artery in older HIV-infected adults already receiving virologically suppressive antiretroviral therapy (ART) who are then randomized to either NAC 900 mg twice daily, NAC 1800 mg twice daily, or placebo. The relative efficacy and safety of these two doses of NAC will be assessed.
- Conditions
- HIV, Endothelial Dysfunction, Oxidative Stress
- Being tested
- PharmaNAC (N-acetylcysteine), Matching placebo
- Keywords
- HIV, Endothelial function, Oxidative stress, Cardiovascular disease, N-acetylcysteine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmaNAC (N-acetylcysteine)Dietary supplement
Also called N-acetylcysteine, NAC
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 placeboDietary supplement
Inactive pill that matches PharmaNAC on taste, color, and appearance.
| Study group | Role | What they receive |
|---|---|---|
| PharmaNAC 1800 mg | Experimental | PharmaNAC 900 mg orally twice daily for 8 weeks Receives: Dietary Supplement: PharmaNAC (N-acetylcysteine); Dietary Supplement: Matching placebo |
| PharmaNAC 3600 mg | Experimental | PharmaNAC 1800 mg orally twice daily for 8 weeks Receives: Dietary Supplement: PharmaNAC (N-acetylcysteine) |
| Placebo | Placebo comparator | Matching placebo pills given twice daily for 8 weeks Receives: Dietary Supplement: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Circulating Malondialdehyde Levels
Measure of oxidative stress
Measured: Baseline and 8 weeks
Change in Circulating F2-isoprostane Levels
Oxidative stress measure
Measured: Baseline and 8 weeks
Change in Flow-mediated Dilation (FMD) of the Brachial Artery
Measure of endothelial function
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- BioAdvantex Pharma
- Responsible party
- Principal investigator, Samir K Gupta, MD, MS, Indiana University
- Investigators
- Samir K Gupta, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962961
- Sponsor's protocol ID
- IU SRI 1306011647
- Status last verified
- Dec 2015
- First submitted
- 11 Oct 2013
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Pilot Trial Assessing Two Doses of N-Acetylcysteine on Changes in Oxidative Stress and Endothelial Function in HIV-infected Older Adults Receiving Stable Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT01962961
- Acronym / sponsor ID
- IU SRI 1306011647
- Conditions
- HIV, Endothelial Dysfunction, Oxidative Stress
- Keywords
- HIV, Endothelial function, Oxidative stress, Cardiovascular disease, N-acetylcysteine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- BioAdvantex Pharma
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces oxidative stress and improves vascular function in HIV-infected older adults already on HIV treatment.
Detailed description
The primary objective of this study is to compare 8-week changes in circulating levels of malondialdehyde (MDA), circulating levels of F2-isoprostanes, and flow-mediated dilation (FMD) of the brachial artery in older HIV-infected adults already receiving virologically suppressive antiretroviral therapy (ART) who are then randomized to either NAC 900 mg twice daily, NAC 1800 mg twice daily, or placebo. The relative efficacy and safety of these two doses of NAC will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PharmaNAC 1800 mg | Experimental | Dietary Supplement: PharmaNAC (N-acetylcysteine), Dietary Supplement: Matching placeboPharmaNAC 900 mg orally twice daily for 8 weeks |
| PharmaNAC 3600 mg | Experimental | Dietary Supplement: PharmaNAC (N-acetylcysteine)PharmaNAC 1800 mg orally twice daily for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Matching placeboMatching placebo pills given twice daily for 8 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 infection, documented by (1) any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or (2) by two detectable HIV-1 antigens, or (3) two detectable plasma HIV-1 RNA viral loads.
- Age equal to or greater than 50 years.
- Receipt of antiretroviral therapy of any kind for at least 6 months prior to screening.
- HIV-1 RNA level < 75 copies/mL at screening.
- For women who are still of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study. Acceptable forms of birth control include condoms (with or without a gel that can kill sperm), a diaphragm or cervical cap (with or without a gel that can kill sperm), an intrauterine device (IUD), or hormonal-based birth control ("the pill").
Key exclusion criteria (28 listed)
- Inability to complete written, informed consent.
- Incarceration at the time of any study visit.
- Known allergy or intolerance to n-acetylcysteine.
- Use of n-acetylcysteine within 180 days of screening.
- Diagnosed vascular disease (history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmaNAC (N-acetylcysteine)Also: N-acetylcysteine, NACPharmaNAC 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). | Dietary supplement | PharmaNAC 1800 mg, PharmaNAC 3600 mg |
| Matching placeboInactive pill that matches PharmaNAC on taste, color, and appearance. | Dietary supplement | PharmaNAC 1800 mg, Placebo |
Primary outcome
Change in Circulating Malondialdehyde Levels
Time frame: Baseline and 8 weeks
Measure of oxidative stress
Change in Circulating F2-isoprostane Levels
Time frame: Baseline and 8 weeks
Oxidative stress measure
Change in Flow-mediated Dilation (FMD) of the Brachial Artery
Time frame: Baseline and 8 weeks
Measure of endothelial function
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir K Gupta, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PharmaNAC (N-acetylcysteine) in people with HIV and Endothelial Dysfunction, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Circulating Malondialdehyde Levels (time frame: Baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.