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NCT00998582 · ClinicalTrials.gov registry record · Phase 4
Artery Elasticity After Switch From Epzicom to Truvada
A Phase 4 study, sponsored by Hennepin Healthcare Research Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT00998582: Clinical Trial Phase 4 study, sponsored by Hennepin Healthcare Research Institute.
NCT00998582 is a Phase 4 study that was terminated before completion, run by Hennepin Healthcare Research Institute. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00998582, a Phase 4 study, was terminated before completion, sponsored by Hennepin Healthcare Research Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent. This pilot study will examine vascular function, a marker of heart disease risk, among patients taking abacavir as part of their HIV medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2) continue to take abacavir.
Primary Outcome
Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.
Interventions
- DRUG Tenofovir disoproxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
Why NCT00998582 stopped before completion
NCT00998582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir disoproxil is the first listed.
NCT00998582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00998582 about?
NCT00998582 is a clinical study titled "Artery Elasticity After Switch From Epzicom to Truvada". Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent. This pilot study will examine vascular function, a marker of heart disease ris...
What is the current status of trial NCT00998582?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2009-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00998582?
The interventions under investigation include: Tenofovir disoproxil (DRUG).
Who is sponsoring clinical trial NCT00998582?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00998582's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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