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 (AMPHORE)

This study has been terminated.
(difficult to include patients)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00937729
First received: July 10, 2009
Last updated: February 14, 2012
Last verified: February 2012

July 10, 2009
February 14, 2012
June 2009
January 2011   (final data collection date for primary outcome measure)
viral load compliance [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00937729 on ClinicalTrials.gov Archive Site
statistical analysis of MOS HIV [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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 Containing Enfuvirtide (Fuzeon) Associated With Two Active Molecules

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • HIV1 Infection
  • HIV Infections
Not Provided
enfuvirtide
all patients would received enfuvirtide and and optimised background
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00937729
2008/122/HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Hoffmann-La Roche
Principal Investigator: BORSA-LEBAS Françoise CHU Hôpitaux de Rouen
University Hospital, Rouen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP