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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
History of Changes
  Purpose

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.


Condition
HIV1 Infection
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • viral load compliance [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • statistical analysis of MOS HIV [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
enfuvirtide
all patients would received enfuvirtide and and optimised background

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937729

Locations
France
Borsa-Lebas
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Hoffmann-La Roche
Investigators
Principal Investigator: BORSA-LEBAS Françoise CHU Hôpitaux de Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00937729     History of Changes
Other Study ID Numbers: 2008/122/HP
Study First Received: July 10, 2009
Last Updated: February 14, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by University Hospital, Rouen:
uncompliant patients with virological failure
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013