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NCT00529243 · ClinicalTrials.gov registry record · Phase 3

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

A Phase 3 study, sponsored by Kaiser Permanente.

Completed
Registry status
Phase 3
Development phase
52
Enrollment target

NCT00529243: Completed Phase 3 study, sponsored by Kaiser Permanente.

NCT00529243 is a Phase 3 study that has completed, run by Kaiser Permanente. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00529243, a Phase 3 study, has completed, sponsored by Kaiser Permanente.

COMPLETED
Registry status
Phase 3
Development phase
52 participants
Enrollment target

Study Summary

The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, \< 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen. Hypothesis: HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.

Primary Outcome

To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as \< 75 copies/ml by bDNA assay or \< 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.

Interventions

  • DRUG raltegravir

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2007-09
Est. Completion 2009-09
Phase Phase 3
Kaiser Permanente

294 total trials

What the finished NCT00529243 record still lists

NCT00529243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which raltegravir is the first listed.

NCT00529243 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00529243 about?

NCT00529243 is a clinical study titled "Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects". The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonuclei...

What is the current status of trial NCT00529243?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2007-09. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00529243?

The interventions under investigation include: raltegravir (DRUG).

Who is sponsoring clinical trial NCT00529243?

This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00529243's enrollment target sits among peer trials

52 1841st of 2000 higher than 159 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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Source: ClinicalTrials.gov NCT00529243, the US trial registry maintained by the National Library of Medicine. NCT00529243 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.