At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Atazanavir +1 moredrug
Likely dose
Atazanavir (dose not specified in interventions or arms)AI-extracted
Key inclusion· 5
- ✓Age ≥45 years
- ✓Stable non-atazanavir regimen with tenofovir/emtricitabine plus PI, NNRTI, or raltegravir for ≥3 months
- ✓HIV RNA <200 copies/mL at screening and within prior year
- ✓No treatment interruptions >7 days in 3 months prior to study entry
Key exclusion· 11
- ✕Prior treatment failure on or intolerance to atazanavir
- ✕Known or suspected resistance to atazanavir
- ✕Currently receiving ART regimen other than tenofovir/emtricitabine plus PI/NNRTI/raltegravir
- ✕Currently receiving phosphodiesterase-5 inhibitors (Viagra, Levitra, or Cialis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Atazanavir and Endothelial Function in Older HIV Patients
In Brief
A Phase 3 clinical trial evaluating Atazanavir and Placebo for HIV. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The investigators hypothesize that older subjects with HIV randomly assigned to atazanavir will have increased bilirubin levels, reduced oxidative stress, and improved flow-mediated, endothelium-dependent vasodilation compared to subjects not switched to atazanavir.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
Primary CompletionJun 2015
Study CompletionJun 2016
First PostedJan 2017
TodayJul 2026
First PostedJan 13, 2017
Enrollment StartDec 1, 2011
Primary CompletionJun 1, 2015
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.5 years ago
Interventions
Atazanavirdrug
The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen.
Placeboother
The control group will stay on their baseline regimen