CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
PharmaNAC (N-acetylcysteine) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01962961
NCT01962961Phase 2Completed

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

Indiana University·interventional·Posted Oct 16, 2013·Updated Feb 8, 2016

In Brief

A Phase 2 clinical trial evaluating PharmaNAC (N-acetylcysteine) and Matching placebo for HIV and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBioAdvantex Pharma

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 16, 2013
Enrollment StartOct 1, 2013
Primary CompletionJun 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.7 years ago

Interventions

PharmaNAC (N-acetylcysteine)dietary

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

Inactive pill that matches PharmaNAC on taste, color, and appearance.