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NCT00091741 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects

A Phase 1 study, sponsored by Georgetown University.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT00091741: Completed Phase 1 study, sponsored by Georgetown University.

NCT00091741 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00091741, a Phase 1 study, has completed, sponsored by Georgetown University.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance remains the single most important reason for virological failure and rapidly limits treatment options.

Interventions

  • DRUG Etanercept (Enbrel)

Trial Details

FieldValue
Enrollment Target 10 participants
Est. Completion 2004-10
Phase Phase 1
Georgetown University

227 total trials

What the finished NCT00091741 record still lists

NCT00091741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Etanercept (Enbrel) is the first listed.

NCT00091741 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00091741 about?

NCT00091741 is a clinical study titled "Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects". The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists....

What is the current status of trial NCT00091741?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. Estimated completion is 2004-10.

What interventions are being tested in trial NCT00091741?

The interventions under investigation include: Etanercept (Enbrel) (DRUG).

Who is sponsoring clinical trial NCT00091741?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00091741's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00091741, the US trial registry maintained by the National Library of Medicine. NCT00091741 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.