Phase 2
N=24
N-acetylcysteine to Reduce Oxidative Stress and Improve Endothelial Function in HIV-infected Older Adults
HIV · Endothelial Dysfunction · Oxidative Stress
Bottom Line
View on ClinicalTrials.gov: NCT01962961 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Circulating Malondialdehyde Levels — 0.17; -0.12; -0.00 micromolar
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PharmaNAC (N-acetylcysteine) (Dietary_supplement); Matching placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Circulating Malondialdehyde Levels |
0.17; -0.12; -0.00 | — |
| PRIMARY Change in Circulating F2-isoprostane Levels |
-12.78; -4.84; 11.76 | — |
| PRIMARY Change in Flow-mediated Dilation (FMD) of the Brachial Artery |
0.51; -.046; -1.15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01962961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.