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NCT00727597 · ClinicalTrials.gov registry record · Phase 3
A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
A Phase 3 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT00727597: Completed Phase 3 study, sponsored by Georgetown University.
NCT00727597 is a Phase 3 study that has completed, run by Georgetown University. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00727597, a Phase 3 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.
Primary Outcome
Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue * The inv
Interventions
- DRUG Efavirenz 600mg
- DRUG Boosted Lexiva
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00727597 record still lists
NCT00727597 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Efavirenz 600mg is the first listed.
NCT00727597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00727597 about?
NCT00727597 is a clinical study titled "A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT". The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.
What is the current status of trial NCT00727597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2008-07. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00727597?
The interventions under investigation include: Efavirenz 600mg (DRUG), Boosted Lexiva (DRUG).
Who is sponsoring clinical trial NCT00727597?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00727597's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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