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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)

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ClinicalTrials.gov Identifier: NCT00937729
Recruitment Status : Terminated (difficult to include patients)
First Posted : July 13, 2009
Last Update Posted : February 16, 2012
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief 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.

Condition or disease
HIV1 Infection HIV Infections

Study Design
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Study Type : Observational
Actual Enrollment : 4 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Group/Cohort
enfuvirtide
all patients would received enfuvirtide and and optimised background


Outcome Measures
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Primary Outcome Measures :
  1. viral load compliance [ Time Frame: one year ]

Secondary Outcome Measures :
  1. statistical analysis of MOS HIV [ Time Frame: one year ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00937729     History of Changes
Other Study ID Numbers: 2008/122/HP
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents