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TerminatedNCT00937729AMPHOREUpdated Feb 16, 2012

Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules

An observational study in HIV1 Infection and HIV Infections, sponsored by University Hospital, Rouen. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-16.

Sponsored by University Hospital, Rouen · Observational

Why this study was terminated
difficult to include patients
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4
Ages
18 Years and older
Sex
All
01

Study summary

In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.

02

Conditions studied

  • HIV1 Infection
  • HIV Infections

Keywords

  • uncompliant patients with virological failure
  • Treatment experienced
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 4 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients HIV1 infected in virological failure (viral load > 50 copies/ml) by lack of compliance,old of more than 18 years, who never received enfuvirted and without opportunistic infection, yet treated by almost one molecule of each group.

Inclusion criteria

  • virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.

Exclusion criteria

Exclusion Criteria:

  • hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4 participants (actual)

Groups and cohorts

  • enfuvirtide

    all patients would received enfuvirtide and and optimised background

06

What researchers measure

Primary outcomes

  1. viral load compliance

    Time frame: one year

Secondary outcomes

  1. statistical analysis of MOS HIV

    Time frame: one year

07

Study locations

1 site
  • Borsa-Lebas
    Rouen, 76031, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00937729
Lead sponsor
University Hospital, Rouen
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 13, 2009
Start date
Jun 2009
Primary completion
Jan 2011
Completion
Dec 2011
Last update
Feb 16, 2012

Study contacts

BORSA-LEBAS Françoise
principal investigator · CHU Hôpitaux de Rouen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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